Careers Support Contact Sales
Products

More than a Quality Management System: Tools for the entire MedTech Lifecycle.

Learn More

Featured Capabilities:

Document Management Product Development Design Control Risk Solutions Training Management CAPA Management

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

View Product Tour

Data collection and management designed for MedTech clinical trials.

Learn More

Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys

Get a personalized demo of Greenlight Guru Clinical today.

See the Demo

Learn valuable, career-boosting skills for the Medical Device industry. Get access to hundreds of free resources as well as subscription-based courses and certifications.

Learn More
Solutions
Why Us
Customers
Partners
Company
Resources
ROI Report Cover

Calculate Your ROI
See the Demo
See the Demo
See the Demo

Explore Our Resources

Helping you imagine, introduce, and advance better medical technologies.
Featured eBook

2023 MedTech Industry Benchmark Report

Learn More
eBook

Best QMS Software: Ultimate Guide To Comparing Quality Management System Solutions

Learn More
eBook

Ultimate Guide to ISO 14155:2020 for Medical Devices

Learn More

No results

Case Study

Bernafon’s Clinical Trial Data Management Journey from Excel to Greenlight Guru Clinical

Bernafon overcame all previous challenges with data management and have continued to use Greenlight Guru's EDC software for all clinical trials. They managed to reduce time spent ...

Learn More
Case Study

World Leader in Regenerating Damaged Human Tissues Uses Greenlight Guru Clinical

Kerecis achieved full data compliance in both the US and Europe and managed running trials during the COVID-19 pandemic that limited in-person travel.

Learn More
Case Study

MDR Compliant Prospective & Retrospective Clinical Studies

With Greenlight Guru Clinical, Nobel Biocare continues to run their post-market clinical studies in less time spent on data management and study setup all while maintaining MDR ...

Learn More
Case Study

European IVD Startup Gets Fast, Accurate Clinical Data with Greenlight Guru's EDC System

Obtaining critical clinical data is essential to the startup’s goal of getting their in vitro diagnostic device to market. Greenlight Guru's EDC solution was easy to set up, ...

Greenlight Guru Clinical
Case Study

Clinical Trials on AI-Assessed QTc Measurement Directly from Consumer Smartwatches

Cardiologs selected Greenlight Guru Clinical's eCRF (formerly SMART-TRIAL) with an external API add-on as the solution. This enabled them to run the studies in a single system ...

Learn More
Case Study

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X In Two Years

“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger ...

Greenlight Guru Clinical
Global Medical Device Podcast

From Academia to FDA Clearance (True Quality Roadshow - Boston)

Episode 336

Learn More
Global Medical Device Podcast

Accelerating SaMD Development in a Compliant Agile Way

Episode 335

Learn More
Global Medical Device Podcast

MedTech Funding and Preparing for Due Diligence

Episode 334

Learn More
Case Study

How Creo Medical Streamlined Innovation and Development with Greenlight Guru's QMS Software

Creo Medical chose Greenlight Guru’s connected, purpose-built QMS solution to centralize its documentation and help their quality processes keep pace with their innovative product ...

Learn More
Case Study

Scaling SaMD Company Switches from Paper to Greenlight Guru’s eQMS Solution and Increases Efficiency While Reducing Costs

The organization made the switch from a paper-based QMS to Greenlight Guru’s eQMS solution and was able to save the equivalent of one full-time employee’s salary by streamlining ...

Learn More
Case Study

European IVD Startup Gets Fast, Accurate Clinical Data with Greenlight Guru's EDC System

Obtaining critical clinical data is essential to the startup’s goal of getting their in vitro diagnostic device to market. Greenlight Guru's EDC solution was easy to set up, ...

Learn More
Global Medical Device Podcast

Exploring Breakthrough Device Designation

Episode 333

Learn More
Global Medical Device Podcast

Regulatory Strategy and the Advantage of Diversity in MedTech

Episode 332

Learn More
Webinar

How to Validate an Electronic Data Capture Setup for a Medical Device Clinical Investigation

Join us and discover best practices to validate an EDC system as well as your study setup to avoid discrepancies, compliance issues and ensure data integrity and accuracy.

Learn More
Checklists and Templates

Validation Toolkit

Learn More
Webinar

Busting Mythconceptions about FDA’s Refuse-to-Accept Policy for Cybersecurity

Informative webinar where participants will learn how to confidently navigate the complexities of FDA cybersecurity requirements and enhance medical device submission strategies.

Learn More
Global Medical Device Podcast

28 Days To Save The World - True Quality Roadshow

Episode 331

Learn More
Global Medical Device Podcast

3P510k: What Is a 510k 3rd Party Review & What are the Benefits?

Episode 330

Learn More
Webinar

Preparing Your Technical Documentation under MDR: Proven Tips & Techniques

Free webinar presenting proven techniques and tips for medical device companies to prepare technical documentation per Annex II and Annex III of EU MDR, as well as ways to respond ...

Learn More
Thought Leadership Article

Fifteen Questions to Ask QMS Software Vendors in the Medical Device Industry

By Etienne Nichols, Quality Digest

Learn More
Global Medical Device Podcast

The Right Way to Start a QMS: When, How, & What

Episode 329

Learn More
Global Medical Device Podcast

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Episode 328

Learn More
Global Medical Device Podcast

Understanding the ROI of an eQMS

Episode 327

Learn More
Global Medical Device Podcast

CSA vs. CSV: Modern Validation for Modern MedTech

Episode 326

Learn More
Global Medical Device Podcast

The Role of dFMEA in Risk Management for Medical Devices

Episode 325

Learn More
Global Medical Device Podcast

Management Responsibility: The most important part of a QMS

Episode 324

Learn More
Webinar

Developing IEC 62304 Compliant Software: Proven Tips & Best Practices

Free webinar for medical device professionals to gain the knowledge and strategies necessary to successfully implement IEC 62304 to ensure compliance, while developing superior ...

Learn More
Checklists and Templates

Class 3 Medical Device Content Bundle

Learn More
Checklists and Templates

Class 2 Medical Device Content Bundle

Learn More
Checklists and Templates

Class 1 Medical Device Content Bundle

Learn More
eBook

eQMS Buyer’s Guide: Making the Business Case for a New QMS Solution

Step-by-step guide to building the business case for your new eQMS solution, pitching it to management, and making the transition from your old QMS to one that will help your ...

Learn More
Case Study

How Hart Biologicals Cut Audit Prep Time in Half with a Purpose-Built QMS Platform

Tired of an inefficient and ineffective paper-based QMS, Hart Biologicals chose Greenlight Guru’s connected, purpose-built QMS solution to drastically improve its audit ...

Learn More
Events

2023 Risk Management True Quality Summit Series

With nearly every medical device regulatory agency placing risk management front and center it’s increasingly important understand what the regulations are asking for and which ...

Learn More
Checklists and Templates

Clinical Evaluation Toolkit

Learn More
Webinar

Global UDI Update: Including FDA “Devices Not in GUDID” Letters and EU Legacy Device Extension

Free webinar providing an update on global UDI regulations, including FDA initiatives to improve GUDID data quality and the recent EU Legacy Device Amendment, as well as UDI ...

Learn More
Global Medical Device Podcast

The Combination Products Handbook

Episode 323

Learn More
Global Medical Device Podcast

Leaning into Lean Documentation

Episode 322

Learn More
Global Medical Device Podcast

Cybersecurity and the Future of MedTech

Episode 321

Learn More
Global Medical Device Podcast

Ad Promo and The Difference in Regulatory & Legal

Episode 320

Learn More
Webinar

Showing Substantial Equivalence in All Types of 510(k)s: Minimizing Time & Cost to Market

This free webinar will help medical device companies understand the regulatory expectations for substantial equivalence and how to successfully demonstrate it in all types of ...

Learn More
Webinar

How to Design the Optimal eCRF for MedTech Clinical Investigations

This free webinar covers 10 of the most important factors to consider when designing the optimal eCRF for clinical investigations.

Learn More
Webinar

Understanding the ROI of an eQMS Solution

Free webinar providing valuable insights and proven best practices in three key areas defined in this recent study: improving organizational efficiencies, mitigating risk, and ...

Learn More
Checklists and Templates

Checklist for Protecting your IP throughout the MedTech Lifecycle

Learn More
Global Medical Device Podcast

How AI Can Help You Manage Risk

Episode 319

Learn More
Checklists and Templates

What to Include in Your Quality Assurance Agreement with a Distributor

Learn More
Global Medical Device Podcast

The Tools that Make Clinical Investigations

Episode 318

Learn More
Webinar

Implementing Risk Throughout the Entire Product Lifecycle

This free webinar will provide best practices and actionable tips for MedTech companies to effectively manage Risk across the entire medical device lifecycle.

Learn More
Events

A New Era of Risk Management for MedTech | Greenlight Guru Product Launch Event

Watch the live product launch where we unveil Greenlight Guru's Risk Solutions, revolutionizing risk management and transforming the way you work.

Learn More
Global Medical Device Podcast

Complaint Handling with Medical Device Guru, Brittney McIver

Episode 317

Learn More
Global Medical Device Podcast

Avoiding Potential Issues with your 510(k) Submission

Episode 316

Learn More
Global Medical Device Podcast

Meet a Guru: Brittani Smith

Episode 315

Learn More
Webinar

How To Gain Better Access to Healthcare Decision Makers

In this free webinar, you’ll get a chance to hear from a hospital executive, a MedTech sales leader, and MedTech startup “nerd” as they discuss strategies for navigating the ...

Learn More
Checklists and Templates

QMS Implementation Checklist Template

Learn More
Checklists and Templates

Quality Management System (QMS) Software Vendor Checklist

Learn More
Global Medical Device Podcast

Why Building Supplier Relationships Is So Important

Episode 314

Learn More
Global Medical Device Podcast

Systematic Literature Review for EU MDR

Episode 313

Learn More
Events

To Commercialization & Beyond True Quality Summit Series

Ensuring compliance looks different depending on what phase you’re in (pre-market, post-market, or somewhere in between). That's why we're hosting a virtual summit with ...

Learn More
Webinar

How to Show ROI on Your Clinical Evidence

This free webinar presented by Jon Bergsteinsson, SMART-TRIAL by Greenlight Guru co-founder, and Autumn Lang, PhD, RAC, Director of Clinical Affairs at VeriSkin Inc. covers ...

Learn More
Webinar

Pre-market Medical Device Studies and Good Clinical Practice - Strategies for Success

Jon Bergsteinsson and ISO14155 SME Maria Nyåkern will discuss strategies to successfully fulfill GCP requirements for medical device companies.

Learn More
Global Medical Device Podcast

Building Your Design Controls (and Pitfalls to Avoid)

Episode 312

Learn More
Global Medical Device Podcast

Most Common Problems Found During FDA Inspections in 2022

Episode 311

Learn More
Global Medical Device Podcast

V&V Activities from a Verification Engineer POV - How Hard Could It Be?

Episode 310

Learn More
Global Medical Device Podcast

Understanding the 'Compliance Manager' Role

Episode 309

Learn More
Case Study

Avenda Health Gets SaMD Product to Market Easier with Greenlight Guru’s Purpose-Built QMS

“Greenlight Guru’s Design Controls module is powerful and the traceability present across the entire QMS is my favorite part about the software. It makes remote collaboration so ...

Learn More
Case Study

Oticon Medical Continues Striving for Clinical Excellence

How SMART-TRIAL by Greenlight Guru is helping Oticon Medical, industry-leading medical device manufacturer of hearing aids, and why they have remained loyal customers for years.

Learn More
Webinar

Modernizing Your QMS to Reduce Risk, Improve Quality & Drive Innovation

This free webinar presented by MedTech industry expert, Barret Mueller, to learn what a modern QMS is and what medical device companies should be looking for in a QMS solution.

Learn More
Checklists and Templates

ISO 14971:2019 Gap Analysis Tool

Learn More
Checklists and Templates

15-in-1 MedTech Template Bundle

Learn More
Checklists and Templates

General Safety and Performance Requirements (GSPR) Gap Assessment

Learn More
Case Study

How a Class III Device Company Passed Their ISO 13485:2016 Re-Certification Audit with a Modern QMS and Industry Expertise

“The biggest reason we chose Greenlight Guru was that their eQMS is designed for device manufacturers and developers. It is very specific to our needs”

Learn More
Webinar

Refuse to Accept (RTA) & Additional Information Requests (AIR): How to Avoid Problems with Your Medical Device Submission

During this webinar we will review the available RTA checklists and participants will learn how to design a submission that will pass administrative review and avoid receiving an ...

Learn More
Global Medical Device Podcast

DHF vs. DMR vs. DHR: Understanding the Differences & How They Interact

Episode 308

Learn More
Global Medical Device Podcast

How Communication Affects the Outcomes of Quality Activities

Episode 307

Learn More
Global Medical Device Podcast

Part 2: The Theranos Loophole & Lab Developed Tests

Episode 306

Learn More
Global Medical Device Podcast

Part 1: The Theranos Loophole & Lab Developed Tests

Episode 305

Learn More
Global Medical Device Podcast

Implementing an eQMS after Switching from Paper

Episode 304

Learn More
Global Medical Device Podcast

Essentials of Sterilization for Med Device Professionals

Episode 303

Learn More
Global Medical Device Podcast

UDI: 101

Episode 302

Learn More
Global Medical Device Podcast

Quality Myths and Lessons Learned

Episode 301

Learn More
Global Medical Device Podcast

Determining User Needs for Your Medical Device

Episode 300

Learn More
Global Medical Device Podcast

Fraud in the Healthcare Industry & the Role of Whistleblowers

Episode 299

Learn More
Global Medical Device Podcast

Auditing the Auditor

Episode 298

Learn More
Global Medical Device Podcast

What is MedTech Lifecycle Excellence?

Episode 297

Learn More
Webinar

Alternatives to PMCF Clinical Investigations

In this webinar, leading MedTech experts from QServe and SMART-TRIAL by Greenlight Guru share their insights on alternatives to PMCF clinical investigations and suggest ways ...

Learn More
eBook

Ultimate Guide to Postmarket Surveillance of Medical Devices

This eBook of the Ultimate Guide to Postmarket Surveillance covers the regulations that manufacturers must follow, along with best practices and tips for carrying out PMS ...

Learn More
eBook

Ultimate Guide to ISO 14155:2020 for Medical Devices

The ultimate guide about ISO 14155:2020 and Good Clinical Practices (GCP) packed with valuable insights into how to conduct and plan a clinical investigation.

Learn More
Checklists and Templates

5 Tips for IEC 60601 Submissions

Learn More
Webinar

How to Create Your DHF/TF & RMF for a Hardware or Software Medical Device

This free webinar provides a "how to" for DHF/TF and RMF creation for both SaMD and hardware devices.

Learn More
Webinar

The Ugly Truth About Paper-Based QMS - Making the Switch to eQMS

This webinar will highlight why MedTech companies should be concerned about what tools they use to maintain traceability - from an economical, regulatory, and ethical standpoint, ...

Learn More
Checklists and Templates

EU MDR Economic Operators Guidance Document

Learn More
eBook

2023 MedTech Industry Benchmark Report

Learn More
Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

Learn More
Webinar

MDR by the Numbers: Leveraging New Data for Implementation Planning

Free webinar covering the results of research on recent MDCG guidance, industry and Notified Body surveys, and personal interviews with regulatory stakeholders on first hand ...

Learn More
Case Study

Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

"It’s scalable, it’s repeatable, and it’s audit-ready."

Learn More
Webinar

How to Use Clinical Data for Medical Device Submissions in both EU & US

In this free webinar medical device experts from Avania and SMART-TRIAL by Greenlight Guru share advice and insights on how medical device manufacturers can optimize clinical ...

Learn More
Webinar

How to Collect PMCF Data for Lower Class Devices and WETs

In this free webinar, SMART-TRIAL‘s PMCF expert, Jón Bergsteinsson, teams up with CEO of Evnia, Efstathios Vassiliadis, to present you with a simple, yet powerful tool, to collect ...

Learn More
Webinar

eConsent in Medical Device Clinical Investigations

This webinar will answer the most common questions on eConsent in medical device clinical investigations, with Jon Bergsteinsson and Pall Johannesson co-founders of SMART-TRIAL by ...

Learn More
Events

2023 State of Medical Device True Quality Summit Series

Greenlight Guru's annual 2023 State of Medical Device Industry Report is coming to help you understand the strategies, tactics, and technologies used today to accelerate ...

Learn More
Global Medical Device Podcast

The Best of Jon & Mike Through the Years

Episode 296

Learn More
Global Medical Device Podcast

CDRH Proposed Guidance for FY 2023

Episode 295

Learn More
Case Study

Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months

“Purchasing Greenlight Guru was the best decision for our needs. Their easy-to-use eQMS, SOP Templates, and expert Guru guidance were key to us being able to successfully navigate ...

Learn More
Checklists and Templates

CAPA Report Template

Learn More
Global Medical Device Podcast

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

Episode 294

Learn More
eBook

How to Plan a Clinical Data Management Setup for EDC Systems

Access this free guide on how to plan a clinical data management setup for EDC Systems.

Learn More
Webinar

5 Tips for Designing a Medical Device Study under US FDA Requirements

Register for this free webinar presented by clinical data expert and co-founder of SMART-TRIAL by Greenlight Guru, Páll Jóhannesson, and senior director of clinical operations at ...

Learn More
Global Medical Device Podcast

The Future of Healthcare & How We Get There

Episode 293

Learn More
Global Medical Device Podcast

What "Exempt" Means with Respect to Medical Devices & Regulatory

Episode 292

Learn More
Global Medical Device Podcast

Developing a Regulatory Strategy

Episode 291

Learn More
Checklists and Templates

Quality Event Template Package for CAPAs, Complaints & Nonconformities

Learn More
Checklists and Templates

Clinical Evaluation Procedure Template

Learn More
Checklists and Templates

Checklist to Evaluate Your Quality Control Process

Learn More
Checklists and Templates

Design Transfer to Manufacturing

Learn More
Webinar

FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?

This free, in-depth webinar, presented by regulatory experts Kevin Go and Allison Komiyama, will discuss recent regulatory developments in the Digital Health space, how to apply ...

Learn More
Global Medical Device Podcast

We Achieved ISO Certification! Now what?

Episode 290

Learn More
Global Medical Device Podcast

The Future of Reprocessed Used Medical Equipment

Episode 289

Learn More
Global Medical Device Podcast

The Importance of Cervical Cancer Screening in the U.S.

Episode 288

Learn More
Global Medical Device Podcast

Customer Discovery for Medical Device Companies

Episode 287

Learn More
Global Medical Device Podcast

EUA and the Impending Transition

Episode 286

Learn More
Global Medical Device Podcast

Common QMS Mistakes SaMD Companies Make

Episode 285

Learn More
Global Medical Device Podcast

Design Assurance: The Unsung Heroes of R&D

Episode 284

Learn More
Global Medical Device Podcast

Lessons from an Industry Leader: Playing the Long Game of MedTech

Episode 283

Learn More
Global Medical Device Podcast

7 Common 510(k) Mistakes and How to Avoid Them

Episode 282

Learn More
Global Medical Device Podcast

Best Practices for Clinical Evidence Management

Episode 281

Learn More
eBook

7 Principles to Designing an eCRF

A free guide supplying medical device manufacturers with 7 best practices for how to design an electronic case report form.

Learn More
eBook

The Medical Device Sample Size Cookbook

In-depth guide on the process of sample size calculation for medical device studies.

Learn More
eBook

Ultimate Guide to Device Class Requirements under EU MDR

In-depth guide on medical device classification and requirements under EU MDR.

Learn More
Webinar

Regulatory Due Diligence: Why Pay for Information You Can Get for Free?

In this free, interactive webinar industry expert Michael Drues, PhD, explains what regulatory due diligence is for medical device professionals and how to do it, as well as how ...

Learn More
Checklists and Templates

Medical Device Reporting (MDR) Decision Tree

Learn More
Webinar

Monetizing Software: The Challenges of Commercialization & How to Overcome Them

Join us for a live webinar as industry experts Shawnnah Monterrey, CEO of BeanStock Ventures, Kate Burns, Senior Software Product Manager at Arthrex, and Chris DuPont, CEO of ...

Learn More
Webinar

How to Prepare for IVDR

Free, educational webinar covering pertinent details and established best practices on how to prepare your QMS, technical, and clinical documentation for the upcoming IVDR ...

Learn More
Events

The Future of QMS Requirements True Quality Summit Series

If you don’t have a world-class Quality Management System, you may be falling behind. Your QMS can go beyond compliance as you work to enable a culture of True ...

Learn More
Webinar

Extending IEC 62304’s Software Lifecycle Principles to Electrical and Mechanical in Medical Device Design

In this free, in-depth webinar, Satyajit ‘Sat' Ketkar will explain how these principles can and should be applied to all functions of a medical device, specifically electrical and ...

Learn More
eBook

Ultimate Guide to Supplier Management for Medical Device Companies

Good supplier management is critical to marketing a medical device. This comprehensive guide covers everything you need to know about suppliers and purchasing controls.

Learn More
Global Medical Device Podcast

Building Your Regulatory Strategy for Commercialization

Episode 280

Learn More
Global Medical Device Podcast

Packaging Validation Best Practices

Episode 279

Learn More
Global Medical Device Podcast

Overcoming Submission Deficiencies due to Biocompatibility

Episode 278

Learn More
Global Medical Device Podcast

Does Your CAPA Process Need a CAPA?

Episode 277

Learn More
Global Medical Device Podcast

UDI and the Current State of Global Implementation

Episode 276

Learn More
Global Medical Device Podcast

The Changing Job Market & How it Affects Careers for MedTech Quality Professionals

Episode 275

Learn More
Global Medical Device Podcast

Digitizing your SaMD Testing

Episode 274

Learn More
Global Medical Device Podcast

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Episode 273

Learn More
Global Medical Device Podcast

Guerilla Tactics for Quality Leadership

Episode 272

Learn More
Global Medical Device Podcast

Preventing the Death of Medical Device Sales

Episode 271

Learn More
Webinar

Usability Testing: Why can’t we get it right?

This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will use actual devices as case studies to take a critical look at the way we do ...

Learn More
Webinar

Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)

Join Proxima Clinical Research’s subject matter expert, Director of Regulatory Affairs, Isabella Schmitt, MBA, RAC, who will expand on clinical considerations for software and ...

Learn More
Webinar

Connecting Computer System Validation to Daily Operations

Register for this free, in-depth webinar where Carlos Almeida, District Manager & Vice President, Engineering at SPK and Associates, will walk you through how to manage electronic ...

Learn More
eBook

Ultimate Guide to UDI for Medical Devices

A comprehensive guide to UDI (Unique Device Identification) for medical device manufacturers.

Learn More
Events

Global MedTech Regulatory Trends: True Quality Summit Series

MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being ...

Learn More
Webinar

How to Ensure Your State of Affairs for EU MDR is State of the Art

Register for this free, in-depth webinar as we discuss how State of the Art, in context of the formal MDR and MEDDEV references, impacts Technical Documentation, Risk Analysis, ...

Learn More
Webinar

Considerations for Building Your Own Cloud Device: Regulations, Privacy & Cybersecurity

Register for this free webinar presented by Abbas Dhilawala, CTO of Galen Data, who will describe these challenges and provide considerations that are critical for success.

Learn More
Thought Leadership Article

Three Things MedTech Firms Need to Do for 'True Quality'

By Nick Tippmann, Medical Product Outsourcing

Learn More
Thought Leadership Article

Top Hiring and Recruiting Tips for Med-Tech Companies

By Nick Tippmann, Medical Product Outsourcing

Learn More
Thought Leadership Article

True Quality Experts Weigh in on MedTech Future Trends

By Nick Tippmann, Medical Product Outsourcing

Learn More
Webinar

MDR Transition and Tech File Changes: What Medical Device Companies Need to Know

Register for this free, in-depth webinar presented by Rook Quality Systems Sr. Quality Manager Chandler Thames who will expand on the new MDR requirements, and provide key ...

Learn More
Global Medical Device Podcast

Shifting Sands of SaMD Cybersecurity Regulations

Episode 270

Learn More
Global Medical Device Podcast

Early Stage Territory Planning for Medical Device Companies

Episode 269

Learn More
Global Medical Device Podcast

Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry

Episode 268

Learn More
Global Medical Device Podcast

What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?

Episode 267

Learn More
Thought Leadership Article

Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals

By Etienne Nichols, Project Medtech Podcast

Learn More
Thought Leadership Article

Supplier Quality Management: What MedTech Manufacturers Need to Know

By Nick Tippmann, Med-Tech Innovation

Learn More
Thought Leadership Article

Three Lessons from True Quality 2022

By Nick Tippmann, 24x7 Magazine

Learn More
Webinar

Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device

A free, in-depth webinar covering integrating cloud and other modern computing technologies into the operation of medical devices and what cloud computing can teach us about the ...

Learn More
eBook

Ultimate Guide to Software as a Medical Device (SaMD)

A comprehensive guide to software as a medical device (SaMD) packed with insights into how these products are regulated and what manufacturers should expect when building one.

Learn More
Global Medical Device Podcast

Early Feasibility Studies in Latin America

Episode 266

Learn More
Global Medical Device Podcast

Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry

Episode 265

Learn More
Global Medical Device Podcast

Approaching Cybersecurity & Usability as a SaMD Company

Episode 264

Learn More
Global Medical Device Podcast

The Future of Lateral Flow Test Technology

Episode 263

Learn More
Global Medical Device Podcast

Building a Culture of Quality

Episode 262

Learn More
Global Medical Device Podcast

Bringing Medical Devices Into The Home

Episode 261

Learn More
Global Medical Device Podcast

Demystifying the De Novo Process

Episode 260

Learn More
Global Medical Device Podcast

Challenges for Regulatory Submission: EU vs. US

Episode 259

Learn More
Global Medical Device Podcast

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Episode 258

Learn More
Global Medical Device Podcast

The Future of Cybersecurity

Episode 257

Learn More
Global Medical Device Podcast

Achieving Operational Readiness through Good Project Management

Episode 256

Learn More
Global Medical Device Podcast

Bridging the Gap between Medical Devices and Clinical Data

Episode 255

Learn More
Webinar

Bridging the Gap Between Development and Regulatory Teams

A free, in-depth webinar covering the intersection and friction between development and regulatory teams, with a focus on remedies in the form of processes, tools and approaches, ...

Learn More
Webinar

How to Survive an FDA Inspection

A free, in-depth webinar covering some preventative actions that a medical device company can take to minimize the possibility of receiving a 483 which in some cases could result ...

Learn More
Webinar

Special Controls: What Are They & How Can We Use Them To Our Advantage?

This free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, will cover the basics of special controls, how to know if your device needs them and ...

Learn More
Webinar

How to Proactively Predict & Mitigate Risk throughout the Supply Chain

A free, in-depth webinar covering proactive strategies for predictive risk mitigation throughout the supply chain based on core principles of Risk Based Methodologies as it ...

Learn More
Global Medical Device Podcast

Navigating the Medical Device Single Audit Program (MDSAP)

Episode 254

Learn More
eBook

Selecting the Ideal PMCF Activity

Ultimate guide supplying medical device manufacturers with an overview of both generic and specific PMCF activities, and guidance on when and how to include them in your PMCF plan.

Learn More
Global Medical Device Podcast

Bringing Augmented Reality MedTech to Market

Episode 253

Learn More
eBook

Ultimate Guide to Clinical Evaluation of a Medical Device in the EU

A four-part comprehensive guide to help manufacturers understand the essentials of clinical evaluation for medical devices in the European Union (EU).

Learn More
Global Medical Device Podcast

Making Your Informational Meetings With FDA Valuable & Worthwhile

Episode 252

Learn More
Webinar

Top Things You Should Know When Developing Software as a Medical Device (SaMD)

A free, in-depth webinar presented by Shawnnah Monterrey of Beanstock Ventures who will provide a detailed overview of SaMD, the latest updates to the regulations, and how to ...

Learn More
Webinar

Key Pitfalls To Avoid In Medtech Clinical Data Collection

A free, in-depth webinar presented by clinical data experts Páll Jóhannesson and Jón Bergsteinsson from SMART-TRIAL who will help you avoid common pitfalls that make your ...

Learn More
Thought Leadership Article

Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization

By Etienne Nichols, MedTech Intelligence

Learn More
Global Medical Device Podcast

Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs

Episode 251

Learn More
Global Medical Device Podcast

QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices

Episode 250

Learn More
Global Medical Device Podcast

How Medical Device Intellectual Property Protection Varies by Sector

Episode 249

Learn More
Global Medical Device Podcast

Human Factors & Risk Management: What's Needed & Why?

Episode 248

Learn More
Webinar

Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?

A free in-depth webinar presented by Michael Drues, Ph.D., President of Vascular Sciences, covering the basics of how to prepare a letter-to-file the right way in order to avoid a ...

Learn More
Webinar

Is Regulation Necessary for Quality? How to Improve Your Product & Bottom Line with Compliance & a QMS

A free, in-depth webinar exploring how regulations and standards contribute to the improved safety and overall quality of medical products and directly affect cost and profit.

Learn More
Global Medical Device Podcast

What are the Opportunities for Improvement (OFI) for Quality?

Episode 247

Learn More
Checklists and Templates

How To Prepare An FDA Pre-Submission

Learn More
Checklists and Templates

Periodic Safety Update Report Template

Learn More
Global Medical Device Podcast

Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph

Episode 246

Learn More
Webinar

Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability

A free, in-depth webinar exploring a more efficient process to control and collaborate on product development to streamline work for faster submissions and continuous ...

Learn More
Global Medical Device Podcast

How To Select A Contract Manufacturer

Episode 245

Learn More
Global Medical Device Podcast

A Regulatory Gap Analysis of FDA's Systems & Policies

Episode 244

Learn More
Global Medical Device Podcast

Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat

Episode 243

Learn More
Global Medical Device Podcast

Tips For Being Prepared Post-EUA (Emergency Use Authorization)

Episode 242

Learn More
Events

True Quality 2022

True Quality 2022, Greenlight Guru's inaugural conference, is coming to San Diego June 6-8th. Learn, connect, and find inspiration at the must-attend experience for ...

Learn More
Events

2022 State of Medical Device True Quality Summit Series

Greenlight Guru's annual State of Medical Device Product Development and Quality Management Report is coming to help you understand the strategies, tactics, and technologies ...

Learn More
Webinar

UDI Product Data and EUDAMED, Get Onboard!

A free, in-depth webinar covering best practices for UDI preparations and the future potential impacts to medical device manufacturers as EUDAMED requirements are becoming ...

Learn More
Thought Leadership Article

The End of EUA Is Coming Soon

By Jon Speer, Medical Product Outsourcing

Learn More
Webinar

How to Ace your Internal Audits in 2022

A free, in-depth webinar explaining how to conduct internal audits of core QMS functions and cross-functional collaboration methods you can use to benefit your product, QA/RA, ...

Learn More
Global Medical Device Podcast

Understanding the UDI System for Medical Devices

Episode 241

Learn More
Events

Raising Capital True Quality Summit Series

The Raising Capital True Quality Summit Series is designed to help early-stage medical device, MedTech, and digital health company ...

Learn More
Global Medical Device Podcast

How Augmented Reality (AR) Is Revolutionizing Healthcare

Episode 239

Learn More
Global Medical Device Podcast

Why FDA Is Prioritizing Clinical Decision Support Software & Why You Should Care

Episode 238

Learn More
Global Medical Device Podcast

Why Usability Matters

Episode 237

Learn More
Webinar

How to Effectively Implement the New ISO 14971:2019 & Maintain Your Current Risk File

Free, in-depth webinar covering various key changes to ISO14971 and practical approaches for implementation of the new standard for both new products and legacy products.

Learn More
Case Study

How Puzzle Medical is Putting Together the Pieces for Success with Greenlight Guru

"Greenlight Guru was instrumental in implementing our quality system. With them, we can bring safer, higher-quality medical devices to success while maintaining a quality ...

Learn More
Webinar

Notified Body + Manufacturer Face-off: Inside Scoop from Both Sides on How to Address MDR Misalignment

A free, in-depth webinar covering the inside scoop from off-the-record interviews held with both manufacturers and notified bodies to identify areas of misalignment and ...

Learn More
Webinar

Breakthrough Device Designation & Its Impact on Reimbursement

A free, in-depth webinar covering the benefits and risks associated with FDA Breakthrough Designation and what it means for reimbursement, FDA interactions and time to ...

Learn More
Thought Leadership Article

4 Red Flags Investors Look For When Vetting Your Medical Device Company

By Nick Tippmann, MedTech Intelligence

Learn More
Thought Leadership Article

Risk Management for Medical Devices

By Wade Schroeder, Quality Digest

Learn More
Global Medical Device Podcast

A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology

Episode 236

Learn More
Global Medical Device Podcast

What Are The Top Compliance Issues Plaguing Medical Device Manufacturers?

Episode 235

Learn More
Global Medical Device Podcast

Setting the Record Straight on Usability & Human Factors

Episode 234

Learn More
eBook

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

A comprehensive list of most frequently asked questions and their answers about ISO 15223-1:2021 Fourth Edition, the latest version of the international standard for the ...

Learn More
Global Medical Device Podcast

Project Management for Product Development of Medical Devices

Episode 233

Learn More
Webinar

The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?

A free, in-depth webinar covering the “new” safety and performance based 510k (sp510k).

Learn More
eBook

Ultimate Guide to QA & RA in Medical Device 3D Printing

A white paper to guide users in the medical device industry through every stage of the product development process, from evaluating manufacturing methods and 3D printing ...

Learn More
Global Medical Device Podcast

Assessing the Global Regulatory Landscape

Episode 232

Learn More
eBook

The Risk Management + Design Controls Connection: What Device Makers Need to Know

A valuable resource to help medical device manufacturers bridge the connection between design control and risk management processes in order to design, develop, manufacture, ...

Learn More
Global Medical Device Podcast

Quality Insights from a 40+ Year Veteran of the Medical Device Industry

Episode 231

Learn More
Case Study

How a Partnership with Greenlight Guru is Making This Dental Device Manufacturer Smile

“Partnering with Greenlight Guru provides you with a team that’s on your side, who are all medical device industry pros and understand what companies like ours go ...

Learn More
Case Study

How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical

“Having partners with common values is just as important as the product or services themselves.”

Learn More
Webinar

The Power of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations to Use for Additive Manufacturing

A free, in-depth webinar covering various additive manufacturing methods and 3D printing technologies companies can use for making medical devices, validating workflows, and ...

Learn More
Global Medical Device Podcast

When to Throw the Least Burdensome Flag on FDA

Episode 230

Learn More
Webinar

Tips & Tricks for Customizing a Clinical Trials Program for your Medical Device, IVD, or Digital Therapeutic that Satisfies Regulators, Investors & Patients

A free, in-depth webinar covering what to expect and do for a successful clinical trials program and market launch for Non-significant Risk (NSR) devices, IVDs, Software as a ...

Learn More
Global Medical Device Podcast

Past, Present, Future State (and World) of Quality in the Medical Device Industry

Episode 229

Learn More
Global Medical Device Podcast

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

Episode 228

Learn More
Checklists and Templates

Abbreviated 510(k) Submission Checklist

Learn More
Checklists and Templates

Checklist For Selecting Suppliers + Contract Manufacturers

Learn More
Checklists and Templates

FDA Labeling Requirements Checklist

Learn More
Checklists and Templates

Checklist: Premarket Submission Documentation for Devices Containing Software

Learn More
Events

Get to Market True Quality Summit Series

Whether you’re bringing your first device to market, or you have launched multiple already, our upcoming True Quality Summit Series is for you. There’s a variety of ...

Learn More
Events

Risk Management True Quality Summit Series

The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives ...

Learn More
Global Medical Device Podcast

Addressing the 'Who, What, When' of Quality in the Medical Device Industry

Episode 227

Learn More
Webinar

Human Factors Engineering: The Worldwide Guide for Medical Device Manufacturers

Free, in-depth webinar covering the human factors engineering process and how to comply with the applicable regulatory requirements of the US, UK, EU, and other international ...

Learn More
Global Medical Device Podcast

Meet a Guru: Maryann Mitchell

Episode 226

Learn More
Global Medical Device Podcast

Why Storytelling Matters for Medical Device Companies

Episode 225

Learn More
Webinar

Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes

A free, in-depth webinar covering BDD and STeP application processes and why getting these designations early in the regulatory process can help clear a device’s pathway to ...

Learn More
Global Medical Device Podcast

A Breakthrough Device that Aims to Prevent Osteoporosis

Episode 224

Learn More
Global Medical Device Podcast

Understanding FDA's New Intended Use Rule and its Implications

Episode 223

Learn More
Webinar

5 Key Points to Consider in Design Transfer of Medtech

Free, in-depth webinar presented by Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate QA/RA at ...

Learn More
Checklists and Templates

Checklist for Structuring Your Technical Documentation

Learn More
Global Medical Device Podcast

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Episode 222

Learn More
Webinar

10 QMS Musts for SaMD and Devices Featuring Software (and how to best utilize for product & team success)

A free, in-depth webinar covering the best practices for setting up an agile QMS which can be adapted and optimized concurrently with software as a medical device (SaMD) ...

Learn More
Checklists and Templates

Approved Supplier List Form Template

Learn More
Global Medical Device Podcast

Tips for Running Better Management Reviews

Episode 221

Learn More
Webinar

FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy

Free, in-depth webinar presented by regulatory experts from the Greenlight Guru Regulatory Advisory Board, where they will compare and contrast FDA versus EU regulatory ...

Learn More
Global Medical Device Podcast

Meet a Guru: Ryan Behringer

Episode 220

Learn More
Global Medical Device Podcast

Navigating the MedTech Cybersecurity Ecosystem

Episode 219

Learn More
Thought Leadership Article

EU MDR Preparedness: How Is COVID-19 a Factor?

By Jon Speer, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Managing Clinical Data Activities

Episode 218

Learn More
Thought Leadership Article

How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests

By Brandon Henning, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Explaining the Role of Importer under EU MDR

Episode 217

Learn More
Webinar

Attention ⚠️ ISO 15223-1 4th Edition is Almost Here: How to Update your Medical Device Labeling to Comply with the New Requirements

This free, in-depth webinar will cover the latest updates of ISO 15223-1 4th Edition to help participants understand the full scope of changes and uncover actionable ...

Learn More
Global Medical Device Podcast

Preparing Your Pre-Submission with the Content FDA Wants to See

Episode 216

Learn More
Global Medical Device Podcast

How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021

Episode 215

Learn More
Global Medical Device Podcast

How New Training Partnership is Advancing Medical Device Knowledge & Professional Development

Episode 214

Learn More
Global Medical Device Podcast

Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020

Episode 213

Learn More
Global Medical Device Podcast

How Mindset Training Can Help Your Team Operate at Peak Performance

Episode 212

Learn More
Thought Leadership Article

Closed-Loop Traceability for FDA Compliance

By Jon Speer, Quality Digest

Learn More
Global Medical Device Podcast

Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

Learn More
Webinar

Combination Products: What Are They, Why Are They Important & Why Should Medical Device Professionals Care?

Free interactive webinar exploring ...

Learn More
Global Medical Device Podcast

Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead

Episode 210

Learn More
Global Medical Device Podcast

Building Your Brand as a Medical Device Professional

Episode 209

Learn More
Checklists and Templates

Clinical Investigation Report Checklist

Learn More
Global Medical Device Podcast

Understanding the Value of a Medical Device Guru

Episode 208

Learn More
Checklists and Templates

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end ...

Learn More
Global Medical Device Podcast

Meet a Guru: Etienne Nichols

Episode 207

Learn More
Global Medical Device Podcast

Meet a Guru: Laura Court

Episode 206

Learn More
Global Medical Device Podcast

Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205

Learn More
Global Medical Device Podcast

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Episode 204

Learn More
Webinar

How to Prepare for and Manage Audits/Inspections across Global Markets

In this free, exclusive webinar event, Greenlight Guru founder Jon Speer will moderate a panel of industry experts in a lively discussion about audits and inspections.

Learn More
Global Medical Device Podcast

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203

Learn More
Checklists and Templates

Content Toolkit for Medical Device Startups

Learn More
Checklists and Templates

MDR & IVDR Gap Analysis Toolkit

Learn More
Global Medical Device Podcast

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Episode 202

Learn More
Global Medical Device Podcast

Managing Business Risk as a Medical Device Company

Episode 201

Learn More
Thought Leadership Article

Preparing for the EU’s MDR

By Nick Tippmann, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200

Learn More
Global Medical Device Podcast

For the Love of Internal Auditing

Episode 199

Learn More
Global Medical Device Podcast

Similarities & Differences between In Vitro Diagnostic (IVD) Devices & Medical Devices

Episode 198

Learn More
Webinar

Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device

A free, in-depth webinar on how manufacturers can evaluate whether biocompatibility testing and risk mitigations are necessary when making changes to a medical ...

Learn More
Global Medical Device Podcast

Knowing vs. Doing as Medical Device Professionals

Episode 197

Learn More
Thought Leadership Article

What Are the Biggest Changes under EU MDR?

By Jon Speer, MedTech Intelligence

Learn More
Global Medical Device Podcast

Pivoting Operations to Meet PPE Demand during Pandemic

Episode 196

Learn More
Global Medical Device Podcast

Pros & Cons of Being a Physician turned MedTech Inventor

Episode 195

Learn More
Global Medical Device Podcast

3 Systems of Risk for Medical Devices from FDA

Episode 194

Learn More
Global Medical Device Podcast

Quality Management for IVD Devices vs Medical Devices

Episode 193

Learn More
Webinar

How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle

A free, in-depth webinar explaining how to integrate cybersecurity into existing medical device development processes, resulting in secure products and needed artifacts for ...

Learn More
Global Medical Device Podcast

Understanding the Investigational Device Exemption (IDE) Process

Episode 192

Learn More
eBook

2021 EU MDR Preparedness Study

In this report, we wanted to provide you with a holistic ...

Learn More
eBook

State of Medical Device Quality Management and Product Development Report

Understand what today’s medical device professionals are doing or using to accelerate product development, ensure compliance, and promote quality based on original research ...

Learn More
Global Medical Device Podcast

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Episode 191

Learn More
Thought Leadership Article

Using Quality as an Advantage in 2021

By Jon Speer, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

Episode 190

Learn More
Thought Leadership Article

Three Reasons Automation and Training Are Essential in Your MDQMS

By Jon Speer, Medical Product Outsourcing

Learn More
Thought Leadership Article

What Is Quality Culture and Does Your Company Have It?

By Jon Speer, Medical Device and Diagnostic Industry

Learn More
Thought Leadership Article

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer, MedTech Intelligence

Learn More
Global Medical Device Podcast

What is the Safer Technologies Program (STeP) and Can Your Device Use It?

Episode 189

Learn More
Global Medical Device Podcast

Meet a Guru: Sara Adams

Episode 188

Learn More
Case Study

How IVD Manufacturer Streamlined Production and Improved Quality Processes with an Industry-Specific QMS

"If I were to quantify it, it's days of time saved. The cost of Greenlight Guru is repaid in efficiency."

Learn More
Global Medical Device Podcast

Why the PMA Process is so Dreaded by Manufacturers in the US Market

Episode 187

Learn More
Checklists and Templates

5 Steps for Creating a Traceability Matrix

Learn More
Global Medical Device Podcast

Building a Startup in the MedTech Industry

Episode 186

Learn More
Global Medical Device Podcast

Meet a Guru: Karen Schuyler

Episode 185

Learn More
Global Medical Device Podcast

Visualizing a Medical Device through Illustrations, Animations, and other Artwork

Episode 184

Learn More
Global Medical Device Podcast

Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

Learn More
Checklists and Templates

Medical Device Project Plan

Learn More
Events

EU MDR & IVDR True Quality Summit Series

Whether you've fully transitioned, are just getting started, or are planning to enter the EU market in the future, you won't want to miss this free virtual summit that covers ...

Learn More
Events

2021 State of Medical Device Virtual Summit

The two day, digital event dives into perspectives, predictions, and experiences of industry leaders and takes a deep dive into the ...

Learn More
Global Medical Device Podcast

Preparing for Remote and On-Site Inspections and Audits

Episode 182

Learn More
Global Medical Device Podcast

How does EU MDR impact your Quality Management System?

Episode 181

Learn More
Checklists and Templates

510(k) Program Comparison Chart

Learn More
Global Medical Device Podcast

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

Learn More
Case Study

How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS

"Greenlight Guru was the only way we could get our small team to move really quickly with a QMS."

Learn More
Global Medical Device Podcast

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

Episode 179

Learn More
eBook

Ultimate Guide to Training Management for Medical Device Companies

Comprehensive guide to help medical device companies learn about training management, including compliance requirements and proven ways to promote total competence of the ...

Learn More
Global Medical Device Podcast

Prioritizing Medical Device Reimbursement During Product Development

Episode 178

Learn More
Checklists and Templates

Total Quality Management 4-in-1 Tool

Learn More
Global Medical Device Podcast

5 Actionable Lessons Learned from the RADx Initiative by NIH

Episode 177

Learn More
Checklists and Templates

Legacy vs Best-in-Class QMS Tools Comparison Chart

Learn More
Global Medical Device Podcast

What are the Strategic Priorities for CDRH in 2021?

Episode 176

Learn More
Checklists and Templates

Change Impact Analysis Template

Learn More
Global Medical Device Podcast

Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

Episode 174

Learn More
Webinar

Change Management and Risk Management: How do we connect the dots and what happens if we don’t?

Free interactive webinar demonstrating how to integrate change management and risk management and will share best practices using case studies from a variety of clinical ...

Learn More
Checklists and Templates

Change Order Template

Learn More
Global Medical Device Podcast

Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

Episode 173

Learn More
Checklists and Templates

Nonconformance Report Template

Learn More
Global Medical Device Podcast

Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

Episode 172

Learn More
Checklists and Templates

Free Replay Package: 2021 Medical Device Virtual Summit

Learn More
Checklists and Templates

Checklist: 7 Steps to Comply with FDA 21 CFR Part 11

Learn More
Global Medical Device Podcast

How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

Episode 171

Learn More
Thought Leadership Article

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann, Medical Product Outsourcing

Learn More
Thought Leadership Article

Imagine It’s 2030: What Was the Key To Business Success During COVID-19?

By David DeRam, Inside INdiana Business

Learn More
Thought Leadership Article

Traceability Requirements in EU MDR

By Jon Speer, Medical Device and Diagnostic Industry (MD+DI)

Learn More
Global Medical Device Podcast

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Episode 170

Learn More
Checklists and Templates

Value of True Quality Infographic

Learn More
Global Medical Device Podcast

What Goes into Designing Devices for Military and Emergency Applications?

Episode 169

Learn More
eBook

Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices

In-depth guide covering the requirements of 21 CFR Part 820, FDA's quality system regulation for medical devices, including tips on how to comply and avoid common ...

Learn More
eBook

Ultimate Guide to Document Control

In-depth guide for medical device companies on how to control documents and improve procedures, with actionable solutions to common problems with document control activities ...

Learn More
Checklists and Templates

Training Matrix Template

Learn More
Global Medical Device Podcast

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Episode 168

Learn More
Checklists and Templates

Top 100 Medical Device Startups with Most Money Raised in 2020 Chart

Learn More
Thought Leadership Article

Four Essential Processes in Medical Device Risk Management

By Jon Speer, Quality Digest

Learn More
Global Medical Device Podcast

Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

Learn More
Checklists and Templates

Biocompatibility Testing Selection Criteria

Learn More
Webinar

When Do We Need FDA’s Permission to Market Our Device and When Do We Not?

A free, in-depth webinar exploring what is and is not a regulated medical device and how manufacturers can interpret and leverage FDA's definition of a device.

Learn More
Global Medical Device Podcast

Why Biocompatibility Should be Addressed by Every Medical Device Company

Episode 166

Learn More
Checklists and Templates

Human Factors & Usability Engineering Report

Learn More
Global Medical Device Podcast

Meet a Guru: Erica Loring

Episode 165

Learn More
Checklists and Templates

Complaint Template

Learn More
Checklists and Templates

CAPA Template

Learn More
Global Medical Device Podcast

What is a Multiple Function Device?

Episode 164

Learn More
Thought Leadership Article

Adopting a Data-Driven Approach to Quality with an MDQMS

By Jon Speer, Medical Product Outsourcing

Learn More
Checklists and Templates

7 Steps for Writing a Nonconformance Report

Learn More
Thought Leadership Article

The Importance of Managing and Controlling Risk in the Medical Device Industry

By Jon Speer, Quality Digest

Learn More
Webinar

Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking

A free, in-depth webinar covering the best tools and tricks for manufacturers of in vitro diagnostic devices to meet IVDR requirements and obtain CE Marking.

Learn More
Global Medical Device Podcast

Challenges related to Home Use Devices

Episode 163

Learn More
Thought Leadership Article

Why I Left a MedTech Manufacturer For a Software Scale-Up

By Wade Schroeder, Inside INdiana Business

Learn More
Global Medical Device Podcast

Submitting a 510(k) using FDA's Safety and Performance Based Pathway

Episode 162

Learn More
Webinar

How to Implement and Maintain a Modern CAPA System while Avoiding Common Pitfalls

A free, in-depth webinar covering proven methods to improve your CAPA processes and tactical approaches you can start taking today to ensure the medical devices you design, ...

Learn More
Global Medical Device Podcast

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

Learn More
Thought Leadership Article

Areas to Consider in Medical Device Risk Management

By Jon Speer, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Meet a Guru: Wade Schroeder

Episode 160

Learn More
Webinar

Insider’s look at the IEC 60601 Amendments: Detailed Guidance from Committee Member Responsible for Changes

A free, in-depth webinar covering the significant changes of the IEC 60601 Amendments and how medical device manufacturers and consultants can ...

Learn More
Global Medical Device Podcast

What are the Audit Etiquette Rules I Should be Following?

Episode 159

Learn More
Global Medical Device Podcast

Meet a Guru: Tom Rish

Episode 158

Learn More
Thought Leadership Article

Ensure Success Throughout the Entire Medical Device Lifecycle

By Jon Speer, Medical Device and Diagnostics Industry

Learn More
Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The European Union

By David DeRam, Forbes

Learn More
Global Medical Device Podcast

Addressing Clinical Trial Challenges & Concerns during COVID-19

Episode 157

Learn More
Thought Leadership Article

From the Experts: Best Practices to Ensure Device Success

By Jon Speer, Medical Product Outsourcing

Learn More
Webinar

Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1

A free in-depth webinar covering the most effective verification and testing strategies companies can implement for compliance with ISO 13485:2016, IEC 62034 / 60601-1 / 82304-1.

Learn More
Global Medical Device Podcast

Protecting the Intellectual Property of your Medical Device Technology

Episode 156

Learn More
Global Medical Device Podcast

Meet a Guru: Jesseca Lyons

Episode 155

Learn More
Global Medical Device Podcast

How to Build a QMS for a Medical Device

Episode 154

Learn More
Global Medical Device Podcast

Meet a Guru: Taylor Brown

Episode 153

Learn More
Events

The Greenlight Guru True Quality Virtual Summit

The Greenlight Guru True Quality Virtual Summit is the must-attend experience for medical device quality, regulatory, and product development professionals who drive innovation ...

Learn More
Webinar

Understanding the Medical Device Classification System: From Basics to Beyond – Using Classification to your Competitive Advantage

A free, in-depth webinar covering the medical device classification system and how companies can use it to their competitive advantage by using best practices for ...

Learn More
Webinar

How to Integrate Risk Management throughout the Lifecycle of a Medical Device in the Coming Decade

A free webinar reviewing the application of a modern approach to risk management (risk analysis, risk evaluation, risk control, overall residual risk evaluation, ...

Learn More
Thought Leadership Article

Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic

By Jon Speer, MedTech Intelligence

Learn More
Global Medical Device Podcast

What is Regulatory Due Diligence for Medical Devices?

Episode 152

Learn More
Global Medical Device Podcast

Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief

Episode 151

Learn More
Case Study

How Flexlogical Is Making Quality A Competitive Advantage By Adopting Data-driven Approach With MDQMS

"Showing traceability and documenting takes seconds in Greenlight Guru, compared to hours in a paper-based system."

Learn More
Global Medical Device Podcast

How Being Strategic During A Career Transition Can Yield The Best Opportunities

Episode 150

Learn More
Global Medical Device Podcast

Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry

Episode 149

Learn More
Thought Leadership Article

Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer, Medical Product Outsourcing

Learn More
Checklists and Templates

3 Tips for Receiving EUA from FDA

Learn More
Global Medical Device Podcast

How to Construct an Effective Regulatory Strategy

Episode 148

Learn More
Thought Leadership Article

COVID-19’s Impact on the MedTech Industry: How to Get Through

By Jon Speer, MedTech Intelligence

Learn More
Global Medical Device Podcast

What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)

Episode 147

Learn More
Thought Leadership Article

What You Need to Know for an Effective Risk Assessment

By Jon Speer, Quality Digest

Learn More
Global Medical Device Podcast

How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices

Episode 146

Learn More
Thought Leadership Article

What Consumer Tech Companies Need To Know About Medical Devices In The US

By David DeRam, Forbes

Learn More
Global Medical Device Podcast

510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies

Episode 145

Learn More
Global Medical Device Podcast

Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers

Episode 144

Learn More
Thought Leadership Article

Engineers: How to Curb Quality Myths Now

By Jon Speer, MedTech Intelligence

Learn More
Global Medical Device Podcast

[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem

Episode 143

Learn More
Global Medical Device Podcast

How to Approach Verification and Validation for Cloud Software

Episode 142

Learn More
Global Medical Device Podcast

Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives

Episode 141

Learn More
Webinar

3 Ways Medical Device Companies Working Remote Are Leveraging QMS Software To Foster Innovation And Collaboration

This free in-depth webinar will cover how companies using turn-key, best-in-class QMS software are able to remain agile in order to innovate and outperform the ...

Learn More
Thought Leadership Article

Building a Medtech Firm on a Foundation of Quality

By Nick Tippmann, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know

Episode 140

Learn More
Webinar

How Can Medical Device Companies Use The Emergency Use Authorization (EUA) To Address The Covid-19 Pandemic?

This free in-depth webinar will explore the Emergency Use Authorization — specifically in the context of COVID-19 — and how medical device companies can use it.

Learn More
Checklists and Templates

10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead

Learn More
Global Medical Device Podcast

How to Integrate Usability into your Medical Device

Episode 139

Learn More
Global Medical Device Podcast

[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)

Episode 138

Learn More
Global Medical Device Podcast

How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

Learn More
eBook

Definitive Guide to ISO 14971:2019 Risk Management for Medical Devices

Learn the most up to date recommendations and best practices from the ISO 14971:2019 standard and how you can start to use risk management as a tool - not a checkbox ...

Learn More
Webinar

Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?

This free in-depth webinar will explore all regulatory pathways to market — including the lesser-known and lesser-used ones — to help you decide which to use when for your ...

Learn More
Global Medical Device Podcast

What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

Episode 136

Learn More
Thought Leadership Article

Paper Processes: Three Reasons It’s a Costly Business Move

By Jon Speer, MedTech Intelligence

Learn More
Thought Leadership Article

Paper Is Expensive

By Jon Speer, Quality Digest

Learn More
eBook

Best QMS Software: Ultimate Guide To Comparing Quality Management System Solutions

The best QMS software comparison guide for medical device companies that will help you choose a quality management system solution that strategically benefits your product and ...

Learn More
Webinar

How to Use UX to Streamline Medical Device Product Cycles

A free in-depth webinar outlining a process that not only fits within the regulatory parameters, but also is so effective that it shortens the typical product development cycle ...

Learn More
Global Medical Device Podcast

How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

Learn More
Global Medical Device Podcast

How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

Episode 134

Learn More
Thought Leadership Article

The True Cost of Paper

By Jon Speer, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

4 Parts to Interviewing Candidates for Medical Device Roles

Episode 133

Learn More
Webinar

Key Considerations for SaMD Companies Developing and Commercializing Software as Medical Devices

A free in-depth webinar covering the most important items that companies must understand and put into practice when developing and commercializing SaMDs.

Learn More
Global Medical Device Podcast

5 Tips for Hiring Medical Device Advisors

Episode 132

Learn More
Thought Leadership Article

4 Powerful Ways Mindfulness Encourages Peak Performance

By David DeRam, Forbes

Learn More
Thought Leadership Article

Why Great Companies Don't Run On Spreadsheets

By David DeRam, Forbes

Learn More
Global Medical Device Podcast

2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

Episode 131

Learn More
Thought Leadership Article

3 Keys to Attracting Investors and Raising Funds for Your Med Device

By Jon Speer, Healthcare Business Today

Learn More
Thought Leadership Article

Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer, Medical Product Outsourcing

Learn More
Thought Leadership Article

5 Tips To Raise Funding For Your Medical Device

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer, Medical Product Outsourcing

Learn More
Webinar

Behind the Stats: Medical Device Product Development & Quality Management Benchmark Survey

A free in-depth webinar on industry benchmark survey findings of over 500 medical device professionals around the globe, covering the most compelling stats, biggest surprises, ...

Learn More
eBook

15 Questions to Ask QMS Software Vendors in the Medical Device Industry

Know what questions to ask software vendors that give your medical device company the necessary information to consider when selecting a QMS software solution.

Learn More
Thought Leadership Article

4 Keys to Funding Your Medical Device

By Jon Speer, MedTech Intelligence

Learn More
Webinar

Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent

A free webinar covering the design control “framework” and recommendations to effectively meet their requirements. Emphasis will be placed not only on regulatory aspects but on ...

Learn More
Global Medical Device Podcast

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

Learn More
Global Medical Device Podcast

What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?

Episode 129

Learn More
Webinar

Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)

A free webinar on how you can establish an effective medical device change control process to ensure internal consistency throughout your quality management systems and ...

Learn More
Global Medical Device Podcast

5 Myths about QA/RA Recruiting in the Medical Device Industry

Episode 128

Learn More
Global Medical Device Podcast

How to Solve the Medtech Value Equation with Quality Data

Episode 127

Learn More
Checklists and Templates

IVDR Gap Assessment Tool

Learn More
Global Medical Device Podcast

Why Supplier Quality Management Is So Important

Episode 126

Learn More
Global Medical Device Podcast

FDA is Expanding its Case for Quality Program... Should Your Company Participate?

Episode 125

Learn More
Thought Leadership Article

We’re going through changes: Major upcoming regulatory changes for manufacturers explained

By Jon Speer, Medical Plastics News

Learn More
eBook

Definitive Guide to Change Management for Medical Devices

A definitive guide on change management best practices to help medical device companies understand and manage changes to documents, products, processes and more.

Learn More
Thought Leadership Article

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer, Medtech Intelligence

Learn More
Global Medical Device Podcast

Preparing for EU MDR

Episode 124

Learn More
Thought Leadership Article

A Tsunami of Regulatory Changes is Coming

By Jon Speer, InCompliance

Learn More
Webinar

An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019

A free, in-depth webinar covering the new changes to ISO 14971:2019, the international standard for medical device risk management, and its companion guidance document ISO TR ...

Learn More
Checklists and Templates

MDD vs. MDR Gap Assessment Tool

Learn More
Global Medical Device Podcast

Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction

Episode 123

Learn More
Glossary

IEC 60601

Learn More
eBook

5 Do's And Don'ts When Choosing A Qms Solution For Your Medical Device Company

A guide to the top 5 recommended best practices that medical device companies should consider when choosing a quality management system (QMS) solution.

Learn More
eBook

A Complete Guide to Bringing a Medical Device to Market

A complete guide for medical device manufacturers looking for guidance on how to plan for a successful product launch and maintain regulatory compliance across global ...

Learn More
Checklists and Templates

5 Myths about PMA's (and what's actually true)

Learn More
Thought Leadership Article

Top 4 Mistakes When Implementing ISO 13485

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

Five Tips From Medtech Executives on the Value of Quality

By Jon Speer, Quality Digest

Learn More
Case Study

C2DX, INC. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

"We wanted a QMS solution that was robust enough to grow with us, but simple enough to get us started."

Learn More
Webinar

Post-market Surveillance For Medical Devices And Combination Products: If A Device Is Fda Cleared Or Approved, Can We Assume It’s Safe And Effective?

In this free webinar participants will learn post-market surveillance best practices for medical devices and combination products to avoid timely and costly mistakes, as ...

Learn More
Global Medical Device Podcast

Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?

Episode 122

Learn More
MedTech Stories Podcast

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Evan Luxon Co-founder & CEO, Centese

Learn More
Global Medical Device Podcast

Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents

Episode 121

Learn More
Checklists and Templates

Content Toolkit for Medical Device Executive Leaders

Learn More
Global Medical Device Podcast

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

Learn More
Webinar

How and When to Start Documenting your Formal Design Controls with DHF Ready Ideation

In this free webinar participants will learn how and when to start formal design controls to improve product development through an innovative and proven approach known as DHF ...

Learn More
Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 119

Learn More
Webinar

How And When To Register EU Medical Devices And Report UDI Information To EUDAMED

In this free webinar participants will learn how and when to register EU medical devices and report Unique Device Identification (UDI) information to EUDAMED, manage UDI ...

Learn More
Checklists and Templates

Content Toolkit for Medical Device QA/RA Professionals

Learn More
Checklists and Templates

Content Toolkit for Medical Device Product Developers

Learn More
Global Medical Device Podcast

Implementing Changes to SaMD under New EU MDR

Episode 118

Learn More
Global Medical Device Podcast

Career Tips for QA/RA Professionals in the Medical Device Industry

Episode 117

Learn More
Case Study

Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market

“Greenlight Guru has been instrumental for us while we efficiently navigate the quality management system process and with developing our FDA submission.”

Learn More
Thought Leadership Article

The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer, The MedTech Conference

Learn More
Glossary

IEC 62304

Learn More
Global Medical Device Podcast

Right-sizing your QMS

Episode 116

Learn More
Checklists and Templates

Quality Culture Flowchart

Learn More
Webinar

How To Apply Risk Management Throughout The Product Lifecycle Of Your Medical Device

In this free webinar participants will learn how to apply Risk Management (Risk Analysis, Risk Evaluation, Risk Control, Overall Residual Risk Evaluation, Production and Post ...

Learn More
Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 115

Learn More
MedTech Stories Podcast

Elevating True Quality with Software Medical Device for Early Cancer Detection and Treatment

Chad McClennan President, CEO, Koios Medical, Graham Anderson CFO, Koios Medical, Patricia ...

Learn More
Global Medical Device Podcast

When Should You Start a QMS?

Episode 114

Learn More
eBook

Ultimate Guide To Agile Design And Development For Medical Devices

In-depth overview of Agile design and development processes to improve risk and quality management of medical devices that fulfill user and business needs.

Learn More
Glossary

Bill of Materials

Learn More
Glossary

Root Cause Analysis

Learn More
Global Medical Device Podcast

How General Wellness Devices Have Opened a Pandora's Box of Confusion

Episode 113

Learn More
Webinar

10 Steps To Preparing Your 510(k) Submission (And How To Avoid The Common Pitfalls)

In this free webinar participants will learn about the key steps to take when preparing a 510(k) Premarket Notification and how to avoid common pitfalls that can occur during ...

Learn More
Global Medical Device Podcast

Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device

Episode 112

Learn More
Global Medical Device Podcast

Importance of Software Requirements in Product Development

Episode 111

Learn More
Glossary

Predicate Device

Learn More
MedTech Stories Podcast

Eliminating Subjectivity And Guesswork With A Modernized Solution To Detecting Ear Infections

Ryan Shelton Founder / CEO, PhotoniCare

Learn More
Thought Leadership Article

Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing

Learn More
Thought Leadership Article

Quality Is The Heartbeat Of Your Company

By David Deram, Forbes

Learn More
Global Medical Device Podcast

4 Facts That May Surprise You About FDA

Episode 110

Learn More
Glossary

FDA Warning Letters

Learn More
Webinar

Breakthrough Designation Program: Is This An Option For My Medical Device?

Learn More
Global Medical Device Podcast

Design History File Ready Ideation: An Innovative Approach To Product Development

Episode 109

Learn More
Checklists and Templates

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

Learn More
Global Medical Device Podcast

Looking at the Sunset of FDA's Alternative Summary Reporting Program

Episode 108

Learn More
MedTech Stories Podcast

Creating a Culture of Quality for Medical Device Companies

Devon Campbell Founder, Prodct LLC

Learn More
Global Medical Device Podcast

Challenges with MedTech Innovation

Episode 107

Learn More
Checklists and Templates

21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes

Learn More
Thought Leadership Article

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer, Quality Digest

Learn More
Global Medical Device Podcast

Is Your Medical Device Company CAPA Happy?

Episode 106

Learn More

Product Requirements Guide + Checklist with Writing Tips

Learn More
Global Medical Device Podcast

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

Learn More
Glossary

Standard Operating Procedure for Medical Devices

Learn More
Glossary

EU IVDR

Learn More
Glossary

Technical File vs Design Dosier

Learn More
Glossary

Notified Body

Learn More
Glossary

Human Factors and Usability

Learn More
Glossary

Wearable Medical Devices

Learn More
Glossary

Customer Complaint Handling Process

Learn More
Glossary

QMS Manual

Learn More
Glossary

FDA 510k Clearance

Learn More
Global Medical Device Podcast

Greenlight Guru In the Classroom: A University's Real-world Approach

Episode 104

Learn More
Webinar

Why Design Validation is More than Testing: How do we validate our validation?

In this free webinar participants will learn best practices for design validation, including how to avoid timely and costly validation mistakes and creative ways to use ...

Learn More
eBook

The Essential Guide to Preparing Your QMS for EU MDR

This is the essential guide to help you prepare your Quality Management System (QMS) for the new EU MDR before the transition period ends on May 26, 2020.

Learn More
MedTech Stories Podcast

Improving the Colonoscopy Screening Experience

Alex Ovadia CEO, Check-Cap

Learn More
MedTech Stories Podcast

Advancing MRI Technology As We Know It Today

Schelte Post Project Manager, MR Coils

Learn More
Global Medical Device Podcast

EU MDR: Not All Doom and Gloom

Episode 103

Learn More
Global Medical Device Podcast

Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

Learn More
Thought Leadership Article

Choosing The Right QMS For Your Medical Device Company

By Evan Luxon, Centese (Greenlight Guru customer), MedTech Intelligence

Learn More
Thought Leadership Article

The Most Common Problems With Your CAPA Process

By Jon Speer, ECN

Learn More
Global Medical Device Podcast

How to Make De Novo a Viable Option for your Medical Device

Episode 101

Learn More
Glossary

FDA Form 483

Learn More
Webinar

Understanding Post-market Surveillance under EU MDR: Being Proactive, Not Reactive

A free webinar on the newly codified regulatory requirements for post-market surveillance (PMS) under the new Medical Device Regulations (MDR) that goes into effect May 2020, ...

Learn More
Checklists and Templates

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

Learn More
MedTech Stories Podcast

How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran

Daniel Powell CEO, Spark Biomedical

Learn More
Global Medical Device Podcast

The 100th Episode: A Few of My Favorite Moments

Episode 100

Learn More
Global Medical Device Podcast

Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm

Episode 99

Learn More
Glossary

Quality Assurance Testing

Learn More
Glossary

Quality Assurance Auditing

Learn More
Glossary

ISO 13485 vs 9001

Learn More
Glossary

Quality Assurance Process

Learn More
Glossary

GMP Compliance

Learn More
Glossary

New Product Introduction Process (NPI)

Learn More
Thought Leadership Article

What To Expect During an FDA QSIT Inspection

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

Top 26 Medical Device Conferences To Attend in 2019

By Jon Speer, ECN Magazine

Learn More
Checklists and Templates

EU MDR Gap Analysis Tool

Learn More
Webinar

Why User Needs Matter & Their Benefits in Streamlining Device Design and Development

A free webinar about connecting empathy and purpose to gain meaningful user insights that translate into optimal design inputs and product quality in medical device ...

Learn More
Global Medical Device Podcast

Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices

Episode 98

Learn More
Webinar

UX for Medical Devices: Designing for the Evolving Environment of Technology, Safety, Regulation and Recalls

A free webinar on the ways in which UX design can mitigate human error while reducing both recalls and product development costs.

Learn More
Case Study

Centese Trades in Paper-Based QMS for Medical Device Success Platform & Achieves 510(K) Clearance

"I have a high degree of confidence that as changes to the regulations occur, I won't have to worry about being out of compliance because we are using Greenlight ...

Learn More
Global Medical Device Podcast

Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway

Episode 97

Learn More
Case Study

How Innovere Has Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device Specific eQMS

"With Greenlight Guru, you've got software, but also what amounts to a personal consultant. Those connections are powerful."

Learn More
Case Study

Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process with Greenlight Guru

"I highly recommend Greenlight Guru. They have taken a complex industry and made it into a product that’s simple to use.”

Learn More
Webinar

How to Avoid Common Problems with your Design, Risk, and Validation Documentation

A free webinar on the simple ways you and your team can learn to integrate documentation best practices so you can mitigate risk and systemic issues.

Learn More
MedTech Stories Podcast

How Sonavex went from Concept to FDA Clearance in Just 3 Years

David Narrow CEO, Sonavex

Learn More
Global Medical Device Podcast

How and When to Consider Human Factors

Episode 95

Learn More
Global Medical Device Podcast

Who Should Own Your QMS?

Episode 94

Learn More
Glossary

Quality Control System

Learn More
Global Medical Device Podcast

Design Validation vs. Human Factors Validation

Episode 93

Learn More
Glossary

Unique Device Identification (UDI)

Learn More
Glossary

Document Control System

Learn More
Glossary

21 CFR 803 Medical Device Reporting

Learn More
Webinar

Prepping your QMS for EU MDR

A free webinar on the critical steps that are needed in order to prepare your Quality Management System (QMS) for the upcoming EU Medical Device Regulations (EU MDR) in ...

Learn More
Global Medical Device Podcast

Medical Device Product Development Value Proposition

Episode 92

Learn More
Webinar

When Design Input Requirements Go Wrong

A free webinar on what happens when Design Inputs, which are widely regarded as the most important design control element, go wrong.

Learn More
Global Medical Device Podcast

Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies

Episode 91

Learn More
Global Medical Device Podcast

Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?

Episode 90

Learn More
Global Medical Device Podcast

Aligning True Quality and Compliance with MDDAP

Episode 89

Learn More
Glossary

FDA 510(k) Database

Learn More
Global Medical Device Podcast

Explaining the Significance of Voluntary Consensus Standards

Episode 88

Learn More
Webinar

EU MDR: How do I interpret the new regulations and what do I need to do to be compliant?

Free webinar on how to interpret European Union’s Medical Device Regulation (EU MDR), what it means to each organization, and what you can do to be compliant in the EU.

Learn More
Thought Leadership Article

Creating an It Factor Culture

By David Deram, The Sales Evangelist

Learn More
Thought Leadership Article

2019 MedTech Predictions

By Jon Speer, MedTech Intelligence

Learn More
Global Medical Device Podcast

Medical Device Industry Predictions for 2019

Episode 87

Learn More
Glossary

MedWatch Form

Learn More
Glossary

Medical Device Regulations

Learn More
Glossary

ISO Medical Device Standards

Learn More
Glossary

MDSAP

Learn More
Glossary

Electronic Medical Device Reporting

Learn More
Glossary

MEDDEV Vigilance

Learn More
Glossary

eQMS

Learn More
Glossary

Quality Management Process

Learn More
Glossary

Medical Device Clinical Trials

Learn More
Glossary

Medical Device Life Cycle

Learn More
Global Medical Device Podcast

FDA Plans to Modernize 510(k) - Is the Sky Falling?

Episode 86

Learn More
Global Medical Device Podcast

Understanding the Blurred Lines Between Consumer Tech and MedTech

Episode 85

Learn More
Global Medical Device Podcast

Understanding The Differences Between Clearance vs Approval vs Granted

Episode 84

Learn More
Thought Leadership Article

6 Best Practices for Complying with ISO 13485:2016

By Jon Speer, Medical Product Outsourcing

Learn More
Global Medical Device Podcast

Streamlining The Device Marketing Authorization Process

Episode 83

Learn More
Webinar

FDA Partners with Greenlight Guru: Case for Quality Webinar Series

Free webinar series presented by FDA Case for Quality Manager Cisco Vincenty in partnership with Greenlight Guru. This four-part webinar series covers the future of FDA's ...

Learn More
eBook

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices

ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices offers industry professionals everything related to the topic. Greenlight Guru eQMS ...

Learn More
Global Medical Device Podcast

The New Special 510(k)

Episode 82

Learn More
Global Medical Device Podcast

What's New With PMAs

Episode 81

Learn More
Glossary

Labeling Medical Devices

Learn More
Webinar

The 510k and Substantial Equivalence: Why do so many get it wrong?

Learn More
Glossary

Medical Device Reporting

Learn More
Glossary

Document Control Standards

Learn More
Glossary

Document Control SOP

Learn More
Glossary

Document Control Plan

Learn More
Glossary

FDA cGMP

Learn More
Glossary

Electronic Batch Records

Learn More
Checklists and Templates

Suggested Quality Domain Metrics

Learn More
Checklists and Templates

Compliance or Quality Focused Comparison Chart

Learn More
Checklists and Templates

What Influences SaMD Classification?

Learn More
Checklists and Templates

Benefits of a Formal Document Management Solution

Learn More
Checklists and Templates

5 FDA 510(k) Submission Mistakes to Avoid

Learn More
Checklists and Templates

What Medical Device Investors Want to See Checklist

Learn More
Checklists and Templates

FDA Program Comparison Table

Learn More
Checklists and Templates

4 Cornerstones of an Effective eQMS

Learn More
Checklists and Templates

6 Ways AI is Transforming Healthcare

Learn More
Checklists and Templates

Top 100 Medical Device Companies in the World Chart

Learn More
Checklists and Templates

5 Practical R&D Tips for Medical Device Developers

Learn More
Checklists and Templates

10 Key Questions for Defining User Needs

Learn More
Checklists and Templates

7 Tips for Incorporating Human Factors into Device Design

Learn More
Checklists and Templates

Tips to Building Consistent QMS Procedures

Learn More
Checklists and Templates

5 Tips for a Competitive Regulatory Strategy

Learn More
Checklists and Templates

5 Tips for Better DHF Management Cheat Sheet

Learn More
Checklists and Templates

Most Common Sources of Post-market Surveillance Data

Learn More
Checklists and Templates

15 Steps to Create a Risk-based CAPA Process Infographic

Learn More
Checklists and Templates

Ultimate List of Medical Device Incubators & Accelerators

Learn More
Checklists and Templates

4 Steps to Gathering Accurate Complaint Data

Learn More
Checklists and Templates

Overview of a Customer Complaint-handling Procedure

Learn More
Checklists and Templates

Guide to When to Use Different Tools for CAPA Analysis

Learn More
Checklists and Templates

FDA 483 & Warning Letter Checklist

Learn More
Checklists and Templates

510(k) Submission Checklist

Learn More
Checklists and Templates

Cheat Sheet on Preparing Your Team for an FDA Inspection

Learn More
Checklists and Templates

7 Signs You're Ready for an eQMS

Learn More
Checklists and Templates

5 Ways to Prepare Your Team for an FDA Inspection

Learn More
Checklists and Templates

Using Your 510(k) Submission for Design Controls and DHF Table

Learn More
Checklists and Templates

5 Tips for Using a Predicate Device

Learn More
Checklists and Templates

4 Signs You Need to Issue a CAPA

Learn More
Checklists and Templates

Key Elements of Your Design History File Checklist

Learn More
Checklists and Templates

10 Resources to Get Medical Device Companies on Track

Learn More
Checklists and Templates

5 Key Steps for Getting Your Medical Device CE Mark

Learn More
Checklists and Templates

Sample Management Review Template

Learn More
Checklists and Templates

Tips to Help Define User Needs

Learn More
Checklists and Templates

4 Helpful Tips for Better Management of Your Design History File

Learn More
Checklists and Templates

9 Tips for Password Compliance with 21 CFR Part 11

Learn More
Checklists and Templates

4 Reasons the Root Cause Isn't "User Error" Cheatsheet

Learn More
Checklists and Templates

What FDA Expects to See as Part of Your CAPA Process Cheatsheet

Learn More
Checklists and Templates

5 Step Checklist to Determine If a CAPA Is Required

Learn More
Checklists and Templates

Checklist for Selecting Suppliers to Your Medical Device Company

Learn More
Checklists and Templates

4 Methods for Root Cause Analysis Cheat Sheet

Learn More
Checklists and Templates

7 Rules for Effective Medical Device Design Controls Cheat Sheet

Learn More
Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

Learn More
Checklists and Templates

5 Tips for a Successful 510(k) Submission

Learn More
Checklists and Templates

8 Quick Facts about CAPA Cheat Sheet

Learn More
Checklists and Templates

ISO 13485:2016: Changes You Should Know About

Learn More
Checklists and Templates

ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table

Learn More
Checklists and Templates

Failure Mode Effects Analysis (FMEA) Template

Learn More
Checklists and Templates

Medical Device Product Development Checklist

Learn More
Checklists and Templates

FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

Learn More
Checklists and Templates

Budgeting for MedTech Clinical Activities Checklist

Securing the budget for clinical activities can be daunting, especially when you don't know where to start. Here's a checklist to break it down for you with key considerations on ...

Learn More
Checklists and Templates

21 CFR Part 11 compliance checklist for clinical records and e-signatures

Here are our pointers on what you should be aware of if you're looking to achieve compliance with FDA's 21 CFR Part 11, particularly when collecting or maintaining clinical data.

Learn More
Checklists and Templates

Checklist for Clinical Data Collection and Efficient Study Setup

Preparing for clinical data collection is a very important step. This checklist will help you consider some of the most important items before setting up your clinical study.

Learn More
Checklists and Templates

FDA 483/Warning Letter Response Template

Learn More
Checklists and Templates

Risk Management Plan Template

Learn More
Glossary

ISO 13485 Audit

Learn More
Webinar

5 QMS Elements that must Connect to your Design Control for an Effective, Audit Proof Process

Learn More
Global Medical Device Podcast

How to Efficiently Raise Funds for Your Medical Device Company

Episode 80

Learn More
Webinar

Standards, Standards, Standards – Makes the Medical Device World go Around

Free webinar presented by the FDA and Greenlight Guru. Learn about IMDRF, its forthcoming guidance, and how its priorities play in relation to international medical electrical ...

Learn More
Global Medical Device Podcast

7 Habits of Highly Effective True Quality Medical Device Professionals

Episode 79

Learn More
Glossary

Corrective Action Plan

Learn More
Glossary

Risk Matrix

Learn More
eBook

15 Reasons Medical Device Companies Choose Greenlight Guru

This eBook provides 15 reasons you need a solution such as Greenlight Guru that provides built-in compliance, provides traceability, takes little time to implement, and is ...

Learn More
Thought Leadership Article

Why Paper-Based Systems No Longer Make the Cut

By David DeRam, MedTech Intelligence

Learn More
Thought Leadership Article

5 Tips for Post-Market Medical Device Compliance

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

Why Cloud Software Companies Should Build for Vertical Industries

By David DeRam, DZone

Learn More
Thought Leadership Article

5 Reasons Design Controls and Risk Management Processes Fail

By Jon Speer, Medical Product Outsourcing

Learn More
Thought Leadership Article

Cloud Companies Should Build for Vertical Industries

By David DeRam, InformationWeek

Learn More
Thought Leadership Article

How to Avoid a Medtech Document Scavenger Hunt

By Jon Speer, MedCity News

Learn More
Global Medical Device Podcast

Regulatory Tips & Observations from a Former FDA Reviewer

Episode 78

Learn More
Global Medical Device Podcast

Questions to Ask Before Hiring Your Consultant

Episode 77

Learn More
Webinar

How to Conquer Supplier Management for Medical Device Companies

Free webinar presented by Kyle Rose of Rook Quality Systems and Greenlight Guru. Learn to conquer supplier management by updating your processes and using best practices to ...

Learn More
Global Medical Device Podcast

What You Need to Know About The FDA CDRH Experiential Learning Program

Episode 76

Learn More
Global Medical Device Podcast

Latest Updates on CDRH Standards Program and IEC 60601

Episode 75

Learn More
Webinar

FDA's Case for Quality: Non-Product Computer System Validation (Part 4 of 4)

Learn More
eBook

21 CFR Part 11: A Complete Guide

We'll take you through each section of 21 CFR Part 11, FDA's regulation for electronic documentation and electronic signatures. We'll explain what the ...

Learn More
Global Medical Device Podcast

15 Habits of Highly Effective Regulatory Professionals

Episode 74

Learn More
Global Medical Device Podcast

How to Embrace Risk for Safer Devices

Episode 73

Learn More
Global Medical Device Podcast

What you Need to know About FDA's Progressive Programs

Episode 72

Learn More
Webinar

The Pre-Market Approval (PMA): Is it really as bad as so many think?

Learn More
Global Medical Device Podcast

What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

Episode 71

Learn More
eBook

Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016

Learn how to manage all the changes to your medical device QMS to comply with the new regulations & standards; EU MDR, EU IVDR & ISO 13485:2016.

Learn More
eBook

Why Paper-Based Quality Management Systems are No Longer an Option

Paper-based quality management systems are no longer an option. The right quality management software platform can save time, money, and allow you to focus on quality.

Learn More
eBook

A Step-by-Step Guide to Preparing Your FDA 510(K) Submission

Looking to submit your FDA 510k? This step by step guide provides step-by-step instructions on preparing an FDA 510(k) submission to gain market clearance.

Learn More
eBook

The Art of Design Inputs and Design Outputs

The art of defining design inputs & design outputs for FDA compliance by medical device manufacturers.

Learn More
Global Medical Device Podcast

The Bleeding Edge: Lessons Learned for the Medical Device Industry

Episode 70

Learn More
Global Medical Device Podcast

AI Explainability: What that Means and Why it Matters in the Medical Device Industry

Episode 69

Learn More
Global Medical Device Podcast

How Human Factors Impact Your Medical Device

Episode 68

Learn More
Webinar

FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)

Learn More
Global Medical Device Podcast

How to Think About Quality and Regulatory as Your Company Scales

Episode 67

Learn More
Webinar

10 Things You Must Know About Updating Your Technical Files to Comply with EU MDR

Learn More
Global Medical Device Podcast

How to Design for Compliance with IEC60601

Episode 66

Learn More
Glossary

CORRECTIVE ACTION VS PREVENTIVE ACTION

Learn More
Glossary

CORRECTIVE AND PREVENTIVE ACTION FORM

Learn More
Glossary

CORRECTIVE AND PREVENTIVE ACTION REPORT

Learn More
Glossary

NONCONFORMANCE MANAGEMENT

Learn More
Glossary

CORRECTIVE ACTION PROCEDURE

Learn More
Glossary

POSTMARKET SURVEILLANCE

Learn More
Glossary

MEDICAL DEVICE DESIGN

Learn More
Glossary

ISO 13485 REQUIREMENTS

Learn More
Global Medical Device Podcast

FDA Allows Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

Episode 65

Learn More
Global Medical Device Podcast

How to Use the Abbreviated FDA 510(K) Pathway to Your Advantage

Episode 64

Learn More
Global Medical Device Podcast

Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not be as Scary as You Think)

Episode 63

Learn More
Thought Leadership Article

Five Common Mistakes Companies Make With CAPA

By Jon Speer, Quality Digest

Learn More
Webinar

FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm

Greenlight Guru has partnered with FDA to give you the inside track on what you need to know about the Case for Quality, the changing regulatory paradigm, and what all this ...

Learn More
Case Study

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X In Two Years

“Not having your Design control or Risk Management can be a $20M hair cut on the valuation of your company. I’ve seen first hand a small company being courted by a bigger ...

Learn More
Thought Leadership Article

Why the FDA Presubmission Is an Underutilized Tool

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

A timeline to adopt medical device QMS (and why you need to act now)

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

How To Structure Your Internal Audit Program

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

Here’s what you need to know about FDA’s new guidance on software as a medical device

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups — Here Are 5 Tips You Can Steal

By David DeRam, Business 2 Community

Learn More
Thought Leadership Article

How to streamline the customer complaint handling process

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

The Impact of Risk Management on CAPA

By Jon Speer, Medical Device and Diagnostics Industry

Learn More
Thought Leadership Article

The Countdown to Implementing ISO 13485:2016

By Jon Speer, Medical Device and Diagnostics Industry

Learn More
Thought Leadership Article

Greenlight Guru Revenue Rockets In Q4, Plans Hiring Spree In Q1

By Greenlight Guru, Med Device Online

Learn More
Thought Leadership Article

How to Integrate Complaint Handling and Risk Management

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

5 things to address if you’re a medical device startup

By Jon Speer, Med-Tech Inovation

Learn More
Thought Leadership Article

What should really trigger a CAPA?

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

Why the best engineers are attracted to big problems

By David Odmark, Techpoint

Learn More
Thought Leadership Article

5 predictions for the medical device industry in 2018 (and how you can prepare)

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

The potential impact of FDA’s use of PRO to assess effects of medical devices

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

How CAPA Connects to Other QMS Processes

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

What a Risk-Based QMS Means

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

5 Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer, Diagnostic and Interventional Cardiology

Learn More
Thought Leadership Article

The 5 Most Common Problems With Your CAPA Process

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?

By Jon Speer, Medical Device and Diagnostics Industry

Learn More
Thought Leadership Article

Design Validation vs. Clinical Evaluation: What's the difference?

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

How to prepare your medical device company for an FDA inspection

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer, Mass Device

Learn More
Thought Leadership Article

How to define and decode your design inputs and design outputs

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

7 Common Mistakes That Sink FDA 510(k) Clearance

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

Elite Sports Teams Are Much Better at Creating Powerful Cultures Than Startups -- Here Are 5 Tips You Can Steal

By David DeRam, Entrepreneur

Learn More
Thought Leadership Article

How to Debunk the Most Common CAPA Myths

By Jon Speer, The MedTech Conference

Learn More
Thought Leadership Article

Proper Design Controls Could Save You $20 Million

By Jon Speer, Medical Product Outsourcing

Learn More
Thought Leadership Article

Why Your Medical Device QMS Should Match the Size of Your Company

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

15 Startup Secrets You Can Steal From Sports Cultures

By David DeRam, Powderkeg

Learn More
Thought Leadership Article

How to Prepare Your Design History File For An FDA Inspection

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

Debunking 8 commonly held CAPA myths

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Medical device product development: pitfalls you need to avoid

By John Speer, MassDevice

Learn More
Thought Leadership Article

Medical device product development: 7 pitfalls you need to avoid

By Jon Speer, Medical Design & Outsourcing

Learn More
Thought Leadership Article

Four Ways to Build an Elite Team (On or Off The Field)

By David DeRam, Inside INdiana Business

Learn More
Thought Leadership Article

What are the best ways to handle medical device customer complaints?

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

What should trigger a CAPA in medical device manufacturing?

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Correcting misconceptions about FDA design controls for the medical device industry

By Jon Speer, MedCity News

Learn More
Glossary

FDA Audit

Learn More
Glossary

Document Control

Learn More
Webinar

Bridging User Needs & Design Requirements

Learn More
Case Study

How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification

"As a design firm, our ISO 13485 certification is a competitive advantage. Greenlight Guru made getting it easy."

Learn More
Case Study

How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification

"I was actually a little nervous going into the audit, because it seemed too effortless."

Learn More
Glossary

EU MDR

Learn More
Glossary

MEDDEV 2.7/1

Learn More
Glossary

FDA QSR

Learn More
Glossary

510k vs PMA

Learn More
Glossary

FDA 483

Learn More
Glossary

Quality Assurance vs Quality Control

Learn More
Glossary

ISO 13485 Standards

Learn More
Glossary

ISO 13485 Certification

Learn More
Glossary

Design Controls

Learn More
Glossary

Medical Device Classes

Learn More
Glossary

Medical Device Design Verification

Learn More
Glossary

What is DHF (Design History File)?

Learn More
Glossary

What is Device Master Record (DMR)?

Learn More
Glossary

What is Device History Record (DHR)?

Learn More
Glossary

ISO 9001

Learn More
Glossary

Quality Management Tools

Learn More
Glossary

CE Marking

Learn More
Glossary

ISO 14971

Learn More
Glossary

Corrective and Preventive Action (CAPA)

Learn More
Glossary

ISO 13485

Learn More
Glossary

510K Submission

Learn More
Glossary

21 CFR 820

Learn More
Glossary

21 CFR Part 11

Learn More
Glossary

QMS (Quality Management System)

Learn More
Glossary

Quality Assurance (QA) Systems

Learn More
Webinar

A Timeline to Comply with ISO 13485:2016 (And What You Need to Be Doing Today)

Learn More
Webinar

General Wellness Devices & Wearables: Regulatory Options You Need to Know

Learn More
Webinar

5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)

Learn More
Webinar

Regulatory Intelligence (Mis)Management in the Medical Device Industry

Learn More
Webinar

How Software Can Be Leveraged to Streamline Device Development

Learn More
Webinar

Demystifying the FDA's Human Factors Guidance

Learn More
Global Medical Device Podcast

Tips, Tricks & Best Practices for Complying with ISO 13485:2016

Episode 62

Learn More
Global Medical Device Podcast

Helping to Prepare Biomedical Engineers Entering the Workforce

Episode 61

Learn More
Global Medical Device Podcast

How to Ensure Your Quality Management System is Effective and Benefits Patients

Episode 60

Learn More
Global Medical Device Podcast

5 Most Common Problems with Your CAPA System

Epsidoe 59

Learn More
Global Medical Device Podcast

How to Determine the Operational Quality of a Quality System Using a Performance Assessment

Episode 58

Learn More
Global Medical Device Podcast

What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important

Episode 57

Learn More
Global Medical Device Podcast

Evaluating FDA's "New" Proposed Fast-Track Alternative Approach to the 510(k) Pathway

Episode 56

Learn More
Global Medical Device Podcast

An Overview of What Medical Device Developers Need to Know About Human Factors

Episode 55

Learn More
Global Medical Device Podcast

Challenges with Applying Risk Management Throughout the Manufacturing Process

Episode 54

Learn More
Thought Leadership Article

Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'

By John Speer, Medical Device and Diagnostic Industry

Learn More
Thought Leadership Article

4 key compliance issues for medical device companies

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Five Tips for Medical Device Engineers on FDA Design Controls

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

5 predictions for the medical device industry

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Key Challenges for Risk Management in Medical Device Development

By Jon Speer, Quality Digest

Learn More
Webinar

What You Need to Know About Medical Electrical Standards Updates

Learn More
Webinar

Advanced Strategies and Tactics for Using the De Novo Pathway

Learn More
Global Medical Device Podcast

Common Mistakes That Can Tank Your 510(k) Submission

Episode 53

Learn More
Global Medical Device Podcast

How to Use Real-Word Evidence for Medical Device Regulatory Decisions

Episode 52

Learn More
eBook

Ultimate Guide to FDA Design Controls for Medical Device Companies

How to start using FDA design controls to your benefit today & implement a process to actual improve your medical device product development efforts.

Read the eBook
eBook

Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices

Learn how to implement and maintain a risk-based CAPA process while avoiding the most common pitfalls at your medical device company.

Read the eBook
Webinar

How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAs

Learn More
Webinar

Best Practices for Medical Device Change Management

Learn More
Webinar

How to Create a Risk-based CAPA Process

Learn More
Webinar

Top 10 Most Significant Changes Introduced by the New EU MDR

Learn More
Webinar

How to Prepare for the Medical Device Single Audit Program (MDSAP)

Learn More
Webinar

How QMS Software Can Speed Up Your Product Development & Simplify Compliance

Learn how modern, purpose-built software not only ensures you compliance with all the latest regulations but also frees up your engineers’ time, reduces risk, speeds time to ...

Learn More
Webinar

How to Prepare for a Successful Design Transfer

Learn More
Webinar

How to Prepare for (and Make the Most of) Your FDA Pre-Submission

Learn More
Webinar

Many Connotations of Risk in Medical Device Development

Learn More
Webinar

What You Need to Know About Life with FDA After Your Device Gains Clearance

Learn More
Webinar

5 Things the Medical Device Industry Should Expect in 2017

Learn More
Webinar

15 Steps to Get Approval to IEC 60601-1

Learn More
Webinar

8 Steps to Implement an EU-MDR Compliance Program

Learn More
Webinar

How to Prepare for the New EU Medical Device Regulations (MDR)

Learn More
Webinar

How to Simplify Your Compliance to the New ISO 13485:2016

Learn More
Webinar

How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)

Learn More
Webinar

510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer

Learn More
Webinar

Medical Device Project Management Best Practices

Learn More
Webinar

Clinical Evaluation in the EU for Medical Devices

Learn More
Webinar

How To Avoid and Respond to FDA 483's and Warning Letters

Learn More
Webinar

Everything Device Makers Need to Know About Design Controls

Learn More
Webinar

An Overview of ISO 14971 Risk Management

Learn More
Webinar

Understanding the Changes to ISO 13485:2016

Learn More
Webinar

How To Prepare for the Transition to ISO 13485:2016

Learn More
Global Medical Device Podcast

Lessons to Be Learned From Recent FDA Inspections

Episode 51

Learn More
Global Medical Device Podcast

Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

Episode 50

Learn More
Global Medical Device Podcast

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

Episode 49

Learn More
Global Medical Device Podcast

Comparing FDA Submission Types: 510(k) VS. De Novo VS. 513(G) VS. Pre-Submission

Episode 48

Learn More
Global Medical Device Podcast

How Process Excellence Leads to Product Excellence

Episode 47

Learn More
Global Medical Device Podcast

Understanding FDA’s Proposed Conformity Assessment Pilot Program

Episode 46

Learn More
Global Medical Device Podcast

Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

Episode 45

Learn More
Global Medical Device Podcast

Understanding the Connection Between Complaints, CAPAs, and MDRs

Episode 44

Learn More
Global Medical Device Podcast

The Intersection of Medical Device Usability and Risk Management

Episode 42

Learn More
Global Medical Device Podcast

How FDA Interacts with Medical Devices When They Are Imported into the US

Episode 41

Learn More
Global Medical Device Podcast

How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

Episode 40

Learn More
Global Medical Device Podcast

An Overview of What Device Makers Need to Know About CAPA

Episode 39

Learn More
Global Medical Device Podcast

How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

Episode 38

Learn More
Global Medical Device Podcast

Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

Episode 37

Learn More
Global Medical Device Podcast

What Devicemakers Need to Know About Medical Device Reporting (MDR)

Episode 36

Learn More
Global Medical Device Podcast

How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

Episode 35

Learn More
Thought Leadership Article

3 tips for managing your medical device design history file

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

4 Reasons Your 510(k) Submission Will Be Rejected (And How To Avoid Them)

By Jesseca Lyons, Med Device Online

Learn More
Thought Leadership Article

3 Tips to Reduce the Chance of a 510(k) Submission Rejection

By Jesseca Lyons, Medical Product Outsourcing

Learn More
Thought Leadership Article

Six Tips to Make Sure Your 510(k) Submission Is Accepted

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

6 tips to reduce likelihood of a rejection for an FDA 510(k) submission

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer, Medical Device and Diagnostics Industry

Learn More
Thought Leadership Article

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons, Quality Digest

Learn More
Thought Leadership Article

First-In-Human Studies - What's The Rush?

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

Debunking 4 commonly held design control myths

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Navigating the difficult road of medical device product development while avoiding the common pitfalls

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

Understanding ISO 14971 medical device risk management

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

3 tips for applying risk management across medical device product development

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

The Definitive Guide to Responding to FDA 483 and Warning Letters

By Jon Speer, Medical Design Technology

Learn More
Thought Leadership Article

What were the top reasons FDA issued device makers 483’s and warning letters in 2015

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

8 Reasons Design Controls And Risk Management Processes Fail

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

How design controls apply to a 510(k)

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Get and stay on the FDA's good side with Jon Speer

Inspired Imua Podcast

Learn More
Thought Leadership Article

Why FMEA Is Not ISO 14971

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

Are Design Control Myths Holding Back Your Product Development?

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

A Step-by-Step Guide to Complying with Medical Device QMS Requirements

By Jon Speer, Medical Design Technology

Learn More
Thought Leadership Article

MedTech Blunders in Risk Management

By Jon Speer, MedTech Intelligence

Learn More
Thought Leadership Article

5 Tips to Help Your FDA 510(k) Submission (checklist included)

By Jon Speer, MedCity News

Learn More
Thought Leadership Article

Risk: Look at the Big Picture

By Jon Speer, MedTech Intelligence

Learn More
Thought Leadership Article

How to Prepare for an FDA Inspection

By Jon Speer, Quality Digest

Learn More
Thought Leadership Article

6 Development Steps To Fast-Track Your Medical Device's Path To Market

By Jon Speer, Med Device Online

Learn More
Thought Leadership Article

The Design Controls + Risk Management Connection: Using Design Reviews Effectively

By Jon Speer, Med Device Online

Learn More