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MedTech Lifecycle Excellence Platform

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

State of Medical Device Quality Management and Product Development Report

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eBook

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

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eBook

Ultimate Guide to FDA Design Controls for Medical Device Companies

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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 ...

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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.

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Global Medical Device Podcast

Building Your Regulatory Strategy for Commercialization

Episode 280

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Global Medical Device Podcast

Packaging Validation Best Practices

Episode 279

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Global Medical Device Podcast

Overcoming Submission Deficiencies due to Biocompatibility

Episode 278

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Global Medical Device Podcast

Does Your CAPA Process Need a CAPA?

Episode 277

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Global Medical Device Podcast

UDI and the Current State of Global Implementation

Episode 276

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Global Medical Device Podcast

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

Episode 275

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Global Medical Device Podcast

Digitizing your SaMD Testing

Episode 274

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Global Medical Device Podcast

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

Episode 273

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Global Medical Device Podcast

Guerilla Tactics for Quality Leadership

Episode 272

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Global Medical Device Podcast

Preventing the Death of Medical Device Sales

Episode 271

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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 ...

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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 ...

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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 ...

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eBook

Ultimate Guide to UDI for Medical Devices

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

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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 ...

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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, ...

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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.

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Thought Leadership Article

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

By Nick Tippmann Medical Product Outsourcing July 13th, 2022

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Thought Leadership Article

Top Hiring and Recruiting Tips for Med-Tech Companies

By Nick Tippmann Medical Product Outsourcing July 12th, 2022

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Thought Leadership Article

True Quality Experts Weigh in on MedTech Future Trends

By Nick Tippmann Medical Product Outsourcing July 8th, 2022

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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 ...

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Global Medical Device Podcast

Shifting Sands of SaMD Cybersecurity Regulations

Episode 270

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Global Medical Device Podcast

Early Stage Territory Planning for Medical Device Companies

Episode 269

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Global Medical Device Podcast

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

Episode 268

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Global Medical Device Podcast

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

Episode 267

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Thought Leadership Article

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

By Etienne Nichols Project Medtech Podcast June 27th, 2022

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Thought Leadership Article

Supplier quality management: What medtech manufacturers need to know

By Nick Tippmann Med-Tech Innovation May 17th, 2022

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Thought Leadership Article

Three Lessons from True Quality 2022

By Nick Tippmann 24x7 Magazine May 17th, 2022

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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 ...

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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.

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Global Medical Device Podcast

Early Feasibility Studies in Latin America

Episode 266

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Global Medical Device Podcast

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

Episode 265

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Global Medical Device Podcast

Approaching Cybersecurity & Usability as a SaMD Company

Episode 264

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Global Medical Device Podcast

The Future of Lateral Flow Test Technology

Episode 263

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Global Medical Device Podcast

Building a Culture of Quality

Episode 262

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Global Medical Device Podcast

Bringing Medical Devices Into The Home

Episode 261

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Global Medical Device Podcast

Demystifying the De Novo Process

Episode 260

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Global Medical Device Podcast

Challenges for Regulatory Submission: EU vs. US

Episode 259

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Global Medical Device Podcast

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

Episode 258

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Global Medical Device Podcast

The Future of Cybersecurity

Episode 257

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Global Medical Device Podcast

Achieving Operational Readiness through Good Project Management

Episode 256

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Global Medical Device Podcast

Bridging the Gap between Medical Devices and Clinical Data

Episode 255

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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, ...

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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 ...

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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 ...

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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 ...

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Global Medical Device Podcast

Navigating the Medical Device Single Audit Program (MDSAP)

Episode 254

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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).

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Global Medical Device Podcast

Bringing Augmented Reality MedTech to Market

Episode 253

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Global Medical Device Podcast

Making Your Informational Meetings With FDA Valuable & Worthwhile

Episode 252

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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 ...

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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 ...

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Thought Leadership Article

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

By Etienne Nichols MedTech Intelligence March 24th, 2022

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Global Medical Device Podcast

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

Episode 251

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Global Medical Device Podcast

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

Episode 250

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Global Medical Device Podcast

How Medical Device Intellectual Property Protection Varies by Sector

Episode 249

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Global Medical Device Podcast

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

Episode 248

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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 ...

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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.

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Global Medical Device Podcast

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

Episode 247

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Checklists and Templates

How To Prepare An FDA Pre-Submission

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Checklists and Templates

Periodic Safety Update Report Template

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Global Medical Device Podcast

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

Episode 246

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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 ...

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Global Medical Device Podcast

How To Select A Contract Manufacturer

Episode 245

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Global Medical Device Podcast

A Regulatory Gap Analysis of FDA's Systems & Policies

Episode 244

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Global Medical Device Podcast

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

Episode 243

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Global Medical Device Podcast

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

Episode 242

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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 ...

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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 ...

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Thought Leadership Article

The End of EUA Is Coming Soon

By Jon Speer Medical Product Outsourcing January 7th, 2022

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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, ...

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Global Medical Device Podcast

Understanding the UDI System for Medical Devices

Episode 241

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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 ...

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Global Medical Device Podcast

How Augmented Reality (AR) Is Revolutionizing Healthcare

Episode 239

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Global Medical Device Podcast

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

Episode 238

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Global Medical Device Podcast

Why Usability Matters

Episode 237

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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.

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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 ...

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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 ...

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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 ...

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Thought Leadership Article

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

By Nick Tippmann MedTech Intelligence November 22nd, 2021

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Thought Leadership Article

Risk Management for Medical Devices

By Wade Schroeder Quality Digest September 2nd, 2021

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Global Medical Device Podcast

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

Episode 236

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Global Medical Device Podcast

What Are The Top Compliance Issues Plaguing Medical Device Manufacturers?

Episode 235

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Global Medical Device Podcast

Setting the Record Straight on Usability & Human Factors

Episode 234

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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 ...

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Global Medical Device Podcast

Project Management for Product Development of Medical Devices

Episode 233

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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).

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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 ...

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Global Medical Device Podcast

Assessing the Global Regulatory Landscape

Episode 232

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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, ...

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Global Medical Device Podcast

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

Episode 231

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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 ...

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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.”

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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 ...

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Global Medical Device Podcast

When to Throw the Least Burdensome Flag on FDA

Episode 230

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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 ...

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Global Medical Device Podcast

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

Episode 229

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Global Medical Device Podcast

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

Episode 228

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Checklists and Templates

Abbreviated 510(k) Submission Checklist

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Checklists and Templates

Checklist For Selecting Suppliers + Contract Manufacturers

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Checklists and Templates

FDA Labeling Requirements Checklist

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Checklists and Templates

Checklist: Premarket Submission Documentation for Devices Containing Software

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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 ...

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Events

Risk Management True Quality Summit Series

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

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Global Medical Device Podcast

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

Episode 227

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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 ...

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Global Medical Device Podcast

Meet a Guru: Maryann Mitchell

Episode 226

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Global Medical Device Podcast

Why Storytelling Matters for Medical Device Companies

Episode 225

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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 ...

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Global Medical Device Podcast

A Breakthrough Device that Aims to Prevent Osteoporosis

Episode 224

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Global Medical Device Podcast

Understanding FDA's New Intended Use Rule and its Implications

Episode 223

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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 ...

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Checklists and Templates

Checklist for Structuring Your Technical Documentation

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Global Medical Device Podcast

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Episode 222

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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) ...

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Checklists and Templates

Approved Supplier List Form Template

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Global Medical Device Podcast

Tips for Running Better Management Reviews

Episode 221

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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 ...

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Global Medical Device Podcast

Meet a Guru: Ryan Behringer

Episode 220

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Global Medical Device Podcast

Navigating the MedTech Cybersecurity Ecosystem

Episode 219

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Thought Leadership Article

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

By Jon Speer Medical Product Outsourcing July 6th, 2021

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Global Medical Device Podcast

Managing Clinical Data Activities

Episode 218

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Thought Leadership Article

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

By Brandon Henning Medical Product Outsourcing July 1st, 2021

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Global Medical Device Podcast

Explaining the Role of Importer under EU MDR

Episode 217

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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 ...

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Global Medical Device Podcast

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

Episode 216

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Global Medical Device Podcast

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

Episode 215

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Global Medical Device Podcast

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

Episode 214

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Global Medical Device Podcast

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

Episode 213

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Global Medical Device Podcast

How Mindset Training Can Help Your Team Operate at Peak Performance

Episode 212

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Thought Leadership Article

Closed-Loop Traceability for FDA Compliance

By Jon Speer Quality Digest, June 2nd, 2021

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Global Medical Device Podcast

Examining the HHS Proposal for Premarket Notification Exemptions

Episode 211

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Webinar

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

Free interactive webinar exploring ...

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Global Medical Device Podcast

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

Episode 210

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Global Medical Device Podcast

Building Your Brand as a Medical Device Professional

Episode 209

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Checklists and Templates

Clinical Investigation Report Checklist

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Global Medical Device Podcast

Understanding the Value of a Medical Device Guru

Episode 208

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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 ...

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Global Medical Device Podcast

Meet a Guru: Etienne Nichols

Episode 207

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Global Medical Device Podcast

Meet a Guru: Laura Court

Episode 206

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Global Medical Device Podcast

Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205

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Global Medical Device Podcast

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

Episode 204

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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.

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Global Medical Device Podcast

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203

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Checklists and Templates

Content Toolkit for Medical Device Startups

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Checklists and Templates

MDR & IVDR Gap Analysis Toolkit

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Global Medical Device Podcast

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

Episode 202

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Global Medical Device Podcast

Managing Business Risk as a Medical Device Company

Episode 201

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Thought Leadership Article

Preparing for the EU’s MDR

By Nick Tippmann Medical Product Outsourcing, April 29th, 2021

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Global Medical Device Podcast

Waterfall vs. Agile: Battle of the Product Development Methodologies

Episode 200

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Global Medical Device Podcast

For the Love of Internal Auditing

Episode 199

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Global Medical Device Podcast

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

Episode 198

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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 ...

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Global Medical Device Podcast

Knowing vs. Doing as Medical Device Professionals

Episode 197

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Thought Leadership Article

What Are the Biggest Changes under EU MDR?

By Jon Speer MedTech Intelligence, April 14th, 2021

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Global Medical Device Podcast

Pivoting Operations to Meet PPE Demand during Pandemic

Episode 196

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Global Medical Device Podcast

Pros & Cons of Being a Physician turned MedTech Inventor

Episode 195

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Global Medical Device Podcast

3 Systems of Risk for Medical Devices from FDA

Episode 194

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Global Medical Device Podcast

Quality Management for IVD Devices vs Medical Devices

Episode 193

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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 ...

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Global Medical Device Podcast

Understanding the Investigational Device Exemption (IDE) Process

Episode 192

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eBook

2021 EU MDR Preparedness Study

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

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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 ...

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Global Medical Device Podcast

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

Episode 191

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Thought Leadership Article

Using Quality as an Advantage in 2021

By Jon Speer Medical Product Outsourcing, March 25th, 2021

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Global Medical Device Podcast

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

Episode 190

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Thought Leadership Article

Three Reasons Automation and Training Are Essential in Your MDQMS

By Jon Speer Medical Product Outsourcing, March 15th, 2021

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Thought Leadership Article

What Is Quality Culture and Does Your Company Have It?

By Jon Speer Medical Device and Diagnostic Industry, March 15th, 2021

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Thought Leadership Article

Why You Must Have a Single Source of Truth for CAPA

By Jon Speer MedTech Intelligence, December 15th, 2020

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Global Medical Device Podcast

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

Episode 189

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Global Medical Device Podcast

Meet a Guru: Sara Adams

Episode 188

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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."

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Global Medical Device Podcast

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

Episode 187

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Checklists and Templates

5 Steps for Creating a Traceability Matrix

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Global Medical Device Podcast

Building a Startup in the MedTech Industry

Episode 186

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Global Medical Device Podcast

Meet a Guru: Karen Schuyler

Episode 185

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Global Medical Device Podcast

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

Episode 184

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Global Medical Device Podcast

Everything you Need to Know about SaMD from an FDA Perspective

Episode 183

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Checklists and Templates

Medical Device Project Plan

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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 ...

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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 ...

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Global Medical Device Podcast

Preparing for Remote and On-Site Inspections and Audits

Episode 182

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Global Medical Device Podcast

How does EU MDR impact your Quality Management System?

Episode 181

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Checklists and Templates

510(k) Program Comparison Chart

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Global Medical Device Podcast

Virtual Auditing in a Post-COVID World of Digital Compliance

Episode 180

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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."

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Global Medical Device Podcast

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

Episode 179

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Webinar

3 Ways to Transform your Change Process through AI-powered Predictive Quality

A free, in-depth webinar explaining how to transform the change management process from reactive to predictive quality through AI/ML technologies that enable proactive ...

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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 ...

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Global Medical Device Podcast

Prioritizing Medical Device Reimbursement During Product Development

Episode 178

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Checklists and Templates

Total Quality Management 4-in-1 Tool

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Global Medical Device Podcast

5 Actionable Lessons Learned from the RADx Initiative by NIH

Episode 177

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Checklists and Templates

Legacy vs Best-in-Class QMS Tools Comparison Chart

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Global Medical Device Podcast

What are the Strategic Priorities for CDRH in 2021?

Episode 176

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Checklists and Templates

Change Impact Analysis Template

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Global Medical Device Podcast

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

Episode 174

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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 ...

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Checklists and Templates

Change Order Template

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Global Medical Device Podcast

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

Episode 173

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Checklists and Templates

Nonconformance Report Template

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Global Medical Device Podcast

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

Episode 172

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Checklists and Templates

Free Replay Package: 2021 Medical Device Virtual Summit

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Checklists and Templates

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

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Global Medical Device Podcast

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

Episode 171

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Thought Leadership Article

Expert Roundup: Achieving Success in the 2021 Medical Device Landscape

By Nick Tippmann Medical Product Outsourcing, December 4th, 2020

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Thought Leadership Article

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

By David DeRam Inside INdiana Business, December 3rd, 2020

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Thought Leadership Article

Traceability Requirements in EU MDR

By Jon Speer Medical Device and Diagnostic Industry (MD+DI), November 12th, 2020

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Global Medical Device Podcast

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

Episode 170

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Checklists and Templates

Value of True Quality Infographic

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Global Medical Device Podcast

What Goes into Designing Devices for Military and Emergency Applications?

Episode 169

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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 ...

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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 ...

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Checklists and Templates

Training Matrix Template

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Global Medical Device Podcast

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

Episode 168

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Checklists and Templates

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

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Thought Leadership Article

Four Essential Processes in Medical Device Risk Management

By Jon Speer Quality Digest, September 29th, 2020

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Global Medical Device Podcast

Positive and Negative Impacts of EUA on the Medical Device Industry

Episode 167

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Checklists and Templates

Biocompatibility Testing Selection Criteria

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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.

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Webinar

3 Powerful Ways to Revolutionize Your Approach to Closed-Loop Quality System Traceability

A free, in-depth webinar covering the challenges medical device companies face today when demonstrating closed-loop traceability, the growing emphasis from industry ...

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Global Medical Device Podcast

Why Biocompatibility Should be Addressed by Every Medical Device Company

Episode 166

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Checklists and Templates

Human Factors & Usability Engineering Report

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Global Medical Device Podcast

Meet a Guru: Erica Loring

Episode 165

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Checklists and Templates

Complaint Template

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Checklists and Templates

Nonconformance Template

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Checklists and Templates

CAPA Template

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Global Medical Device Podcast

What is a Multiple Function Device?

Episode 164

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Thought Leadership Article

Adopting a Data-Driven Approach to Quality with an MDQMS

By Jon Speer Medical Product Outsourcing, September 24th, 2020

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Checklists and Templates

7 Steps for Writing a Nonconformance Report

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Thought Leadership Article

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

By Jon Speer Quality Digest, September 8th, 2020

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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.

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Global Medical Device Podcast

Challenges related to Home Use Devices

Episode 163

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Thought Leadership Article

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

By Wade Schroeder Inside INdiana Business, August 6th, 2020

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Global Medical Device Podcast

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

Episode 162

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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, ...

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Global Medical Device Podcast

How Jon Speer Met His Most Frequent Guest: Mike Drues

Episode 161

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Thought Leadership Article

Areas to Consider in Medical Device Risk Management

By Jon Speer Medical Product Outsourcing, August 24th, 2020

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Global Medical Device Podcast

Meet a Guru: Wade Schroeder

Episode 160

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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 ...

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Global Medical Device Podcast

What are the Audit Etiquette Rules I Should be Following?

Episode 159

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Global Medical Device Podcast

Meet a Guru: Tom Rish

Episode 158

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Thought Leadership Article

Ensure Success Throughout the Entire Medical Device Lifecycle

By Jon Speer Medical Device and Diagnostics Industry, August 4th, 2020

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Thought Leadership Article

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

By David DeRam Forbes, July 30th, 2020

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Global Medical Device Podcast

Addressing Clinical Trial Challenges & Concerns during COVID-19

Episode 157

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Thought Leadership Article

From the Experts: Best Practices to Ensure Device Success

By Jon Speer Medical Product Outsourcing, July 27th, 2020

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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.

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Global Medical Device Podcast

Protecting the Intellectual Property of your Medical Device Technology

Episode 156

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Global Medical Device Podcast

Meet a Guru: Jesseca Lyons

Episode 155

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Global Medical Device Podcast

How to Build a QMS for a Medical Device

Episode 154

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Global Medical Device Podcast

Meet a Guru: Taylor Brown

Episode 153

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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 ...

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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 ...

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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, ...

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Thought Leadership Article

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

By Jon Speer MedTech Intelligence, June 24th, 2020

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Global Medical Device Podcast

What is Regulatory Due Diligence for Medical Devices?

Episode 152

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Global Medical Device Podcast

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

Episode 151

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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."

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Global Medical Device Podcast

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

Episode 150

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Global Medical Device Podcast

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

Episode 149

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Thought Leadership Article

Managing and Leading Medical Device Companies and Teams During the Pandemic

By Jon Speer Medical Product Outsourcing, May 28th, 2020

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Checklists and Templates

3 Tips for Receiving EUA from FDA

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Global Medical Device Podcast

How to Construct an Effective Regulatory Strategy

Episode 148

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Thought Leadership Article

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

By Jon Speer MedTech Intelligence, May 19th, 2020

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Global Medical Device Podcast

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

Episode 147

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Thought Leadership Article

What You Need to Know for an Effective Risk Assessment

By Jon Speer Quality Digest, May 14th, 2020

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Global Medical Device Podcast

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

Episode 146

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Thought Leadership Article

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

By David DeRam Forbes, May 8th, 2020

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Global Medical Device Podcast

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

Episode 145

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Global Medical Device Podcast

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

Episode 144

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Thought Leadership Article

Engineers: How to Curb Quality Myths Now

By Jon Speer MedTech Intelligence, April 27th, 2020

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Global Medical Device Podcast

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

Episode 143

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Global Medical Device Podcast

How to Approach Verification and Validation for Cloud Software

Episode 142

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Global Medical Device Podcast

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

Episode 141

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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 ...

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Thought Leadership Article

Building a Medtech Firm on a Foundation of Quality

By Nick Tippmann Medical Product Outsourcing, April 6th, 2020

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Global Medical Device Podcast

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

Episode 140

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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.

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Checklists and Templates

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

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Global Medical Device Podcast

How to Integrate Usability into your Medical Device

Episode 139

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Global Medical Device Podcast

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

Episode 138

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Global Medical Device Podcast

How to Leverage IEC 62304 to Improve SaMD Development Processes

Episode 137

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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 ...

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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 ...

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Global Medical Device Podcast

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

Episode 136

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Thought Leadership Article

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

By Jon Speer MedTech Intelligence, March 6th, 2020

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Thought Leadership Article

Paper Is Expensive

By Jon Speer Quality Digest, February 17th, 2020

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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 ...

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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 ...

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Global Medical Device Podcast

How to Choose the Right FDA Regulatory Pathway for your Device

Episode 135

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Global Medical Device Podcast

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

Episode 134

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Thought Leadership Article

The True Cost of Paper

By Jon Speer Medical Product Outsourcing, February 13th, 2020

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Global Medical Device Podcast

4 Parts to Interviewing Candidates for Medical Device Roles

Episode 133

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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.

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Global Medical Device Podcast

5 Tips for Hiring Medical Device Advisors

Episode 132

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Thought Leadership Article

4 Powerful Ways Mindfulness Encourages Peak Performance

By David DeRam Forbes, February 4th, 2020

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Thought Leadership Article

Why Great Companies Don't Run On Spreadsheets

By David DeRam Forbes, February 3rd, 2020

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Global Medical Device Podcast

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

Episode 131

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Thought Leadership Article

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

By Jon Speer Healthcare Business Today, January 20th, 2020

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Thought Leadership Article

Six Mistakes to Avoid When Implementing ISO 13485

By Jon Speer Medical Product Outsourcing, January 20th, 2020

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Thought Leadership Article

5 Tips To Raise Funding For Your Medical Device

By Jon Speer Medical Design & Outsourcing, January 16th, 2020

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Thought Leadership Article

5 Tips to Raise Investor Interest and Fund Your Medical Device

By Jon Speer Medical Product Outsourcing, January 15th, 2020

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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, ...

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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.

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Thought Leadership Article

4 Keys to Funding Your Medical Device

By Jon Speer MedTech Intelligence, December 27th, 2019

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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 ...

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Global Medical Device Podcast

Navigating the Twists and Turns of Change Management for Medical Devices

Episode 130

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Global Medical Device Podcast

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

Episode 129

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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 ...

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Global Medical Device Podcast

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

Episode 128

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Global Medical Device Podcast

How to Solve the Medtech Value Equation with Quality Data

Episode 127

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Checklists and Templates

IVDR Gap Assessment Tool

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Global Medical Device Podcast

Why Supplier Quality Management Is So Important

Episode 126

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Global Medical Device Podcast

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

Episode 125

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Thought Leadership Article

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

By Jon Speer Medical Plastics News, November 11th, 2019

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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.

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Thought Leadership Article

Top 3 Mistakes You Can Make When Adopting ISO 13485

By Jon Speer Medtech Intelligence, November 8th, 2019

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Global Medical Device Podcast

Preparing for EU MDR

Episode 124

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Thought Leadership Article

A Tsunami of Regulatory Changes is Coming

By Jon Speer In Compliance, October 31st, 2019

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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 ...

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Checklists and Templates

MDD vs. MDR Gap Assessment Tool

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Global Medical Device Podcast

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

Episode 123

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Glossary

IEC 60601

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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.

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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 ...

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Checklists and Templates

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

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Thought Leadership Article

Top 4 Mistakes When Implementing ISO 13485

By Jon Speer Medical Design & Outsourcing, October 30th, 2019

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Thought Leadership Article

Five Tips From Medtech Executives on the Value of Quality

By Jon Speer Quality Digest, October 22nd, 2019

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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."

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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 ...

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Global Medical Device Podcast

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

Episode 122

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MedTech Stories Podcast

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

Evan Luxon Co-founder & CEO, Centese

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Global Medical Device Podcast

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

Episode 121

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Checklists and Templates

Content Toolkit for Medical Device Executive Leaders

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Global Medical Device Podcast

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Episode 120

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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 ...

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Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 119

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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 ...

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Checklists and Templates

Content Toolkit for Medical Device QA/RA Professionals

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Checklists and Templates

Content Toolkit for Medical Device Product Developers

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Global Medical Device Podcast

Implementing Changes to SaMD under New EU MDR

Episode 118

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Global Medical Device Podcast

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

Episode 117

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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.”

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Thought Leadership Article

The Essential Guide To Preparing Your QMS For EU MDR

By Jon Speer The MedTech Conference , August 26th, 2019 How prepared is your quality management system for the new requirements of EU MDR for medical devices that ...

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Glossary

IEC 62304

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Global Medical Device Podcast

Right-sizing your QMS

Episode 116

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Checklists and Templates

Quality Culture Flowchart

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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 ...

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Global Medical Device Podcast

Challenges with Pediatric Medical Devices

Episode 115

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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 ...

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Global Medical Device Podcast

When Should You Start a QMS?

Episode 114

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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.

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Glossary

Bill of Materials

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Glossary

Root Cause Analysis

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Global Medical Device Podcast

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

Episode 113

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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 ...

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Global Medical Device Podcast

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

Episode 112

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Global Medical Device Podcast

Importance of Software Requirements in Product Development

Episode 111

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Glossary

Predicate Device

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MedTech Stories Podcast

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

Ryan Shelton Founder / CEO, PhotoniCare

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Thought Leadership Article

Not All Medical Device QMS Solutions Are Created Equal

By Evan Luxon, Centese (Greenlight Guru customer), Medical Product Outsourcing, June 24th, 2019. As an early-stage medical device company, it may seem simpler to ...

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Thought Leadership Article

Quality Is The Heartbeat Of Your Company

By David Deram, Forbes, June 13th, 2019. Quality is manifested by the level of commitment that’s invested. Quality outcomes don’t happen by chance; they are ...

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Global Medical Device Podcast

4 Facts That May Surprise You About FDA

Episode 110

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Glossary

FDA Warning Letters

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Webinar

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

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Global Medical Device Podcast

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

Episode 109

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Checklists and Templates

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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Global Medical Device Podcast

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

Episode 108

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MedTech Stories Podcast

Creating a Culture of Quality for Medical Device Companies

Devon Campbell Founder, Prodct LLC

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Global Medical Device Podcast

Challenges with MedTech Innovation

Episode 107

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Checklists and Templates

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

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Thought Leadership Article

Qualifying Your Suppliers Using a Risk-Based Approach

By Jon Speer Quality Digest, June 13th, 2019

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Global Medical Device Podcast

Is Your Medical Device Company CAPA Happy?

Episode 106

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Product Requirements Guide + Checklist with Writing Tips

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Global Medical Device Podcast

Integrating Human Factors into Design Controls to Improve Patient Outcomes

Episode 105

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Glossary

Standard Operating Procedure for Medical Devices

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Glossary

EU IVDR

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Glossary

Technical File vs Design Dosier

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Glossary

Notified Body

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Glossary

Human Factors and Usability

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Glossary

Wearable Medical Devices

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Glossary

Customer Complaint Handling Process

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Glossary

QMS Manual

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Glossary

FDA 510k Clearance

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Global Medical Device Podcast

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

Episode 104

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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 ...

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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.

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MedTech Stories Podcast

Improving the Colonoscopy Screening Experience

Alex Ovadia CEO, Check-Cap

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MedTech Stories Podcast

Advancing MRI Technology As We Know It Today

Schelte Post Project Manager, MR Coils

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Global Medical Device Podcast

EU MDR: Not All Doom and Gloom

Episode 103

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Global Medical Device Podcast

Biocompatibility Nuances and its Impact on Medical Devices

Episode 102

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Thought Leadership Article

Choosing The Right QMS For Your Medical Device Company

By Evan Luxon, Centese (Greenlight Guru customer) MedTech Intelligence, May 14th, 2019

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Thought Leadership Article

The Most Common Problems With Your CAPA Process

By Jon Speer ECN, March 25th, 2019

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Global Medical Device Podcast

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

Episode 101

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Glossary

FDA Form 483

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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, ...

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Checklists and Templates

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

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MedTech Stories Podcast

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

Daniel Powell CEO, Spark Biomedical

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Global Medical Device Podcast

The 100th Episode: A Few of My Favorite Moments

Episode 100

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Global Medical Device Podcast

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

Episode 99

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Glossary

Quality Assurance Testing

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Glossary

Quality Assurance Auditing

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Glossary

ISO 13485 vs 9001

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Glossary

Quality Assurance Process

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Glossary

GMP Compliance

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Glossary

New Product Introduction Process (NPI)

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Thought Leadership Article

What To Expect During an FDA QSIT Inspection

By Jon Speer Quality Digest, March 19th, 2019

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Thought Leadership Article

Top 26 Medical Device Conferences To Attend in 2019

By Jon Speer ECN Magazine, February 14th, 2019

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Checklists and Templates

EU MDR Gap Analysis Tool

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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 ...

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Global Medical Device Podcast

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

Episode 98

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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.

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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 ...

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Global Medical Device Podcast

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

Episode 97

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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."

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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.”

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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.

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MedTech Stories Podcast

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

David Narrow CEO, Sonavex

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Global Medical Device Podcast

How and When to Consider Human Factors

Episode 95

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Global Medical Device Podcast

Who Should Own Your QMS?

Episode 94

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Glossary

Quality Control System

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Design Validation vs. Human Factors Validation

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Episode 91

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MEDDEV Vigilance

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The New Special 510(k)

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Electronic Batch Records

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Ultimate List of Medical Device Incubators & Accelerators

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5 Tips for Using a Predicate Device

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

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5 Step Checklist to Determine If a CAPA Is Required

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Checklist for Selecting Suppliers to Your Medical Device Company

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4 Methods for Root Cause Analysis Cheat Sheet

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7 Rules for Effective Medical Device Design Controls Cheat Sheet

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5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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

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Failure Mode Effects Analysis (FMEA) Template

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Medical Device Product Development Checklist

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FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

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Corrective Action Plan

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Risk Matrix

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

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

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Episode 66

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CORRECTIVE ACTION VS PREVENTIVE ACTION

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CORRECTIVE AND PREVENTIVE ACTION FORM

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CORRECTIVE AND PREVENTIVE ACTION REPORT

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NONCONFORMANCE MANAGEMENT

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CORRECTIVE ACTION PROCEDURE

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POSTMARKET SURVEILLANCE

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MEDICAL DEVICE DESIGN

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ISO 13485 REQUIREMENTS

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

Episode 65

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

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How to define and decode your design inputs and design outputs

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

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Proper Design Controls Could Save You $20 Million

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Medical device product development: 7 pitfalls you need to avoid

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FDA Audit

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Document Control

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MEDDEV 2.7/1

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FDA QSR

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Quality Assurance vs Quality Control

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ISO 13485 Standards

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ISO 13485 Certification

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Design Controls

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Medical Device Classes

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Medical Device Design Verification

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What is Device Master Record (DMR)?

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What is Device History Record (DHR)?

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ISO 9001

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Quality Management Tools

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CE Marking

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ISO 14971

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Corrective and Preventive Action (CAPA)

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ISO 13485

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510K Submission

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21 CFR 820

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21 CFR Part 11

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QMS (Quality Management System)

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Quality Assurance (QA) Systems

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

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

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Five Tips for Medical Device Engineers on FDA Design Controls

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5 predictions for the medical device industry

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

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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.

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Global Medical Device Podcast

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

Episode 37

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Global Medical Device Podcast

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

Episode 36

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Global Medical Device Podcast

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

Episode 35

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Thought Leadership Article

3 tips for managing your medical device design history file

By Jon Speer MedCity News October 16th, 2016

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Thought Leadership Article

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

By Jesseca Lyons Med Device Online September 19th, 2016

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Thought Leadership Article

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

By Jesseca Lyons Medical Product Outsourcing Jesseca Lyons on September 15th, 2016

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Thought Leadership Article

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

By Jon Speer Quality Digest August 23rd, 2016

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Thought Leadership Article

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

By Jon Speer MedCity News August 18th, 2016

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Thought Leadership Article

4 Tips for a Smooth 510(k) Submission Process

By Jon Speer Medical Device and Diagnostics Industry August 17th, 2016

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Thought Leadership Article

ISO 14971 or FMEA: Which Should You Use?

By Jesseca Lyons Quality Digest August 9th, 2016

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Thought Leadership Article

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

By Jon Speer Med Device Online July 27th, 2016

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Thought Leadership Article

Debunking 4 commonly held design control myths

By Jon Speer MedCity News July 25th, 2016

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Thought Leadership Article

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

By Jon Speer MedCity News July 14th, 2016

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Thought Leadership Article

Eight Reasons Why Your Design Controls and Risk Management Processes Fail

By Jon Speer Quality Digest July 5th, 2016

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Thought Leadership Article

Understanding ISO 14971 medical device risk management

By Jon Speer MedCity News June 6th, 2016

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Thought Leadership Article

3 tips for applying risk management across medical device product development

By Jon Speer MedCity News May 26th, 2016

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Thought Leadership Article

The Definitive Guide to Responding to FDA 483 and Warning Letters

By Jon Speer Medical Design Technology May 19th, 2016

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Thought Leadership Article

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

By Jon Speer MedCity News May 19th, 2016

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Thought Leadership Article

8 Reasons Design Controls And Risk Management Processes Fail

By Jon Speer Med Device Online May 19th, 2016

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Thought Leadership Article

How design controls apply to a 510(k)

By Jon Speer MedCity News May 5th, 2016

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Thought Leadership Article

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

Inspired Imua Podcast April 21st, 2016

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Thought Leadership Article

Why FMEA Is Not ISO 14971

By Jon Speer Quality Digest April 20th, 2016

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Thought Leadership Article

Are Design Control Myths Holding Back Your Product Development?

By Jon Speer Med Device Online April 1st, 2016

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Thought Leadership Article

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

By Jon Speer Medical Design Technology March 9th, 2016

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Thought Leadership Article

MedTech Blunders in Risk Management

By Jon Speer MedTech Intelligence March 4th, 2016

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Thought Leadership Article

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

By Jon Speer MedCity News March 1st, 2016

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Thought Leadership Article

Risk: Look at the Big Picture

By Jon Speer MedTech Intelligence February 15th, 2016

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Thought Leadership Article

How to Prepare for an FDA Inspection

By Jon Speer Quality Digest February 8th, 2016

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Thought Leadership Article

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

By Jon Speer Med Device Online February 5th, 2016

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Thought Leadership Article

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

By Jon Speer Med Device Online January 10th, 2016

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Thought Leadership Article

An alarming device trend: Why getting 510(k) clearance alone is not enough

By Jon Speer MedCity News December 16th, 2015

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Thought Leadership Article

7 Steps to Respond to FDA 483 Inspection Observations

By Jon Speer MedTech Intelligence November 12th, 2015

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Thought Leadership Article

The Design Controls + Risk Management Connection — Verification, Validation & Risk Controls

By Jon Speer Med Device Online November 16th, 2015

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Thought Leadership Article

The Importance of the Risk Management Plan

By Jon Speer Medical Design Technology November 10th, 2015

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Thought Leadership Article

Design Controls & Risk Management: Two Sides of the Same Coin [Infographic]

By Jon Speer MedCity News November 9th, 2015

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Thought Leadership Article

Risk Management: A Total Product Life-cycle Process [Infographic]

By Jon Speer Legacy MEDSearch November 6th, 2015

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Thought Leadership Article

Risk Management for Medical Devices: An Introduction to the Process [Infographic]

By Jon Speer Qmed November 5th, 2015

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Thought Leadership Article

Risk management definitions you need to understand

By Jon Speer Mass Device November 5th, 2015

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Thought Leadership Article

The beginner's guide to MedTech design verification and validation

By Jon Speer MedCity News October 30th, 2015

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Thought Leadership Article

How to Avoid Exponentially Escalating Costs with Design Controls

By Jon Speer Qmed October 28th, 2015

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Thought Leadership Article

3 Tips for Incorporating Risk Management Throughout Medical Device Product Development

By Jon Speer Medical Design Technology October 20th, 2015

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Thought Leadership Article

The Design Controls + Risk Management Connection — Intended Use & User Needs

By Jon Speer Med Device Online October 19th, 2015

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Thought Leadership Article

5 tips to help you prepare for an FDA inspection

By Jon Speer MedCity News October 13th, 2015

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Thought Leadership Article

4 Reasons Your Risk Management Approach is Wrong

By Jon Speer MedTech Intelligence September 28th, 2015

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Thought Leadership Article

How to make FDA work for you – ATL Device Night

By Nick Tippmann Mass Device September 25th, 2015

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Thought Leadership Article

The $400,000 FDA compliance mistake you don’t want to make

By Jon Speer MedCity News September 23rd, 2015

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Thought Leadership Article

5 Tips For Better Medical Device Risk Management

By Jon Speer Med Device Online September 15th, 2015

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Thought Leadership Article

How to define medical device design inputs and outputs

By Jon Speer MedCity News September 15th, 2015

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Thought Leadership Article

The Beginner's Guide to ISO 14971 Medical Device Risk Management

By Jon Speer Medical Design Technology September 15th, 2015

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Thought Leadership Article

How medical device complaints can make you a better company

By Jon Speer MedCity News September 10th, 2015

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Thought Leadership Article

Case Study: 5 Mistakes that lead to flushing $400,000 in fighting the FDA

By Jon Speer OrthoStreams September 3rd, 2015

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Thought Leadership Article

How to improve your medical device startup’s funding chances

By Jon Speer MedCity News September 1st, 2015

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Thought Leadership Article

Stop Treating Risk Management & Design Controls As Checkbox Activities

By Jon Speer Med Device Online September 1st, 2015

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Thought Leadership Article

Three ways to determine whether your medical device company suffers from disconnect

By Jon Speer MedCity News August 19th, 2015

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Thought Leadership Article

Is your risk management system for medical devices up to date?

By Jon Speer MedCity News August 12th, 2015

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Thought Leadership Article

What's the best approach to medical device Design Reviews?

By Jon Speer MedCity News August 5th, 2015

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Thought Leadership Article

Are We in the Golden Age of Medical Devices?

By Jon Speer Medical Design Technology July 29th, 2015

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Thought Leadership Article

5 Tips To Help Your FDA 510(k) Submission (Checklist Included)

By Jon Speer Med Device Online July 16th, 2015

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Thought Leadership Article

Top Three Document Management Tips for Medical Device Companies

By Jon Speer Quality Digest Jon Speer & Alex Morris on July 8th, 2015

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Thought Leadership Article

3 steps to getting your medical device startup off the ground

By Jon Speer MedCity News July 1st, 2015

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Thought Leadership Article

Regulatory classification 101: A guide to how your medical device will be classified

By Jon Speer MedCity News June 22nd, 2015

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Thought Leadership Article

What issues draw the most attention in FDA medical device inspections?

By Jon Speer MedCity News June 8th, 2015

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Thought Leadership Article

The Medtech Adventures of Eddy the Engineer

By Jon Speer Qmed June 2nd, 2015

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Thought Leadership Article

15 items medical device startups need to address

By Jon Speer MedCity News May 27th, 2015

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Why medical device startups need to master juggling and balancing with focus

By Jon Speer MedCity News May 13th, 2015

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Thought Leadership Article

4 medical device quality system musts for startups

By Jon Speer MedCity News April 30th, 2015

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Thought Leadership Article

The Art Of Medical Device Design Inputs

Med Device Online April 27th, 2015

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Thought Leadership Article

Eight Questions That Define Your Medical Device User Needs

By Jon Speer Quality Digest April 21st, 2015

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Thought Leadership Article

2 things you should do asap when starting a medical device project

By Jon Speer MedCity News April 16th, 2015

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Thought Leadership Article

Your 5 Step Blueprint for Great MedTech Design Reviews

By Jon Speer Qmed April 9th, 2015

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Thought Leadership Article

How to run effective medical device design reviews

By Jon Speer MedCity News April 9th, 2015

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3 Tips for Managing Your Medical Device Design History File

By Jon Speer Medical Design Technology March 31st, 2015

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Thought Leadership Article

From Idea to Market Release: Your Quick Guide to FDA Design Controls

By Jon Speer MedCity News March 30th, 2015

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Thought Leadership Article

How Medtech Startups Can Navigate Design Controls

By Jon Speer Qmed March 12th, 2015

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Global Medical Device Podcast

2016 Medical Device Regulatory Trends Year in Review

Episode 34

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Global Medical Device Podcast

Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

Episode 33

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Global Medical Device Podcast

Tips for Success When It Comes to IEC 60601 with Leo Eisner

Episode 32

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Case Study

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

"Greenlight Guru has already paid for itself in the added value brought to us by successfully flying through our quality audit."

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Global Medical Device Podcast

Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

Episode 31

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Global Medical Device Podcast

Understanding the New FDA Guidance on Changes to 510(k)

Episode 30

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Global Medical Device Podcast

What Device Makers Need To Know About The FDA Pre-Submission Process (Part Two)

Episode 29

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Global Medical Device Podcast

Preparing for the Changes to the EU Medical Device and In-Vitro Diagnostics Regulations

Episode 28

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Global Medical Device Podcast

Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

Episode 27

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Global Medical Device Podcast

Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

Episode 26

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Global Medical Device Podcast

How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

Episode 25

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Global Medical Device Podcast

Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

Episode 24

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Global Medical Device Podcast

Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

Episode 23

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Case Study

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru

The results? "A tenfold increase in efficiency with Greenlight Guru."

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Global Medical Device Podcast

Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

Episode 22

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Global Medical Device Podcast

Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

Episode 21

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Global Medical Device Podcast

Tips to Help You Prepare for an FDA Inspection

Episode 20

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Global Medical Device Podcast

What Device Makers Need to Know About Design Verification and Validation with Mike Drues

Episode 19

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Webinar

How to Manage & Mitigate Risk in New Product Development

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Global Medical Device Podcast

Integrating Business Elements into Your Product Development Process with Therese Graff

Episode 18

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Global Medical Device Podcast

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Episode 17

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Global Medical Device Podcast

The Difference Between Intended Use and Indications of Use with Mike Drues

Episode 16

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Global Medical Device Podcast

Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

Episode 15

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Global Medical Device Podcast

Medical Device Product Development Project Management Best Practices With Peter Sebelius

Episode 14

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Global Medical Device Podcast

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

Episode 13

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eBook

The Risk Management + Design Controls Connection

Everything device makers need to know about the Risk Management + Design Controls connection in medical device product development.

Read the eBook
Global Medical Device Podcast

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

Episode 12

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eBook

Definitive Guide to Responding to FDA 483 & Warning Letters

If you find yourself in this situation, learn how to respond to FDA 483's & warning lettering (includes a free response template)

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eBook

Step-by-step Guide to Complying with ISO 13485 & FDA QSR

A step by step guide to complying with ISO 13485 and FDA quality management system requirements for medical device companies.

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Case Study

The Greenlight Guru Advantage - More Than QMS Software

"I believe the quality system I've institued actually gives me a competitive advantage against a lot of the large companies I used to work for."

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Global Medical Device Podcast

Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

Episode 11

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Global Medical Device Podcast

Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

Episode 10

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Case Study

LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development

"Less than 15 minutes later, the auditor had observed enough evidence to grant the scope expansion."

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Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru

"The proof is in the pudding. We passed our California audit with flying colors. She was in and out in 2 hours and sent us our certificate in the mail, no questions ...

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Global Medical Device Podcast

How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

Episode 9

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Global Medical Device Podcast

How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

Episode 8

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eBook

15 Items Medical Device Startups Need to Address

Here are 15 items medical device startups need to address early on as a best practice to ensuring FDA / ISO regulatory compliance.

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Global Medical Device Podcast

Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

Episode 7

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eBook

Step-by-step Guide to Determine How Your Device Will Be Classified

Greenlight Guru presents a step-by-step guide for determining how your medical device will be classified by U.S. FDA, European Commission, and Health Canada.

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Global Medical Device Podcast

How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

Episode 6

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Global Medical Device Podcast

Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

Episode 5

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Global Medical Device Podcast

Risk Management from a Regulatory & Product Development Point of View

Episode 4

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Global Medical Device Podcast

How to Improve Your Medical Device Design Reviews Bonus Episode

Episode 3 Plus

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Global Medical Device Podcast

How To Improve Your Medical Device Design Reviews

Episode 3

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Global Medical Device Podcast

Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

Episode 2

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eBook

Guide to Design Verification and Design Validation

Learn exactly what design verification and design validation are, how they are the same, how they are different, and best practices for medical devices.

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Global Medical Device Podcast

Best Practices for Implementing Design Controls for the Medical Device Industry

Episode 1

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