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Global Medical Device Podcast
Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond
The Future of Healthcare & How We Get There
What "Exempt" Means with Respect to Medical Devices & Regulatory
Developing a Regulatory Strategy
We Achieved ISO Certification! Now what?
The Future of Reprocessed Used Medical Equipment
The Importance of Cervical Cancer Screening in the U.S.
Customer Discovery for Medical Device Companies
EUA and the Impending Transition
Common QMS Mistakes SaMD Companies Make
Design Assurance: The Unsung Heroes of R&D
Lessons from an Industry Leader: Playing the Long Game of MedTech
7 Common 510(k) Mistakes and How to Avoid Them
Best Practices for Clinical Evidence Management
Building Your Regulatory Strategy for Commercialization
Packaging Validation Best Practices
Overcoming Submission Deficiencies due to Biocompatibility
Does Your CAPA Process Need a CAPA?
UDI and the Current State of Global Implementation
The Changing Job Market & How it Affects Careers for MedTech Quality Professionals
Examining FDA’s Refusal to Accept (RTA) Policy and Guidance
Guerilla Tactics for Quality Leadership
Preventing the Death of Medical Device Sales
Shifting Sands of SaMD Cybersecurity Regulations
Early Stage Territory Planning for Medical Device Companies
Regulatory & Quality Perspectives of 3D Printing in the Medical Device Industry
What Impact Does a QMS & Regulatory Have on Fundraising and Pre-money Valuation?
Early Feasibility Studies in Latin America
Software Bill of Materials (SBOMs) & Cybersecurity in the Medical Device Industry
Approaching Cybersecurity & Usability as a SaMD Company
The Future of Lateral Flow Test Technology
Bringing Medical Devices Into The Home
Demystifying the De Novo Process
Challenges for Regulatory Submission: EU vs. US
From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE
Achieving Operational Readiness through Good Project Management
Bridging the Gap between Medical Devices and Clinical Data
Navigating the Medical Device Single Audit Program (MDSAP)
Bringing Augmented Reality MedTech to Market
Making Your Informational Meetings with FDA Valuable & Worthwhile
Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs
QMSR: The Future of FDA's Quality Management System Regulation for Medical Devices
How Medical Device Intellectual Property Protection Varies by Sector
Human Factors & Risk Management: What's Needed & Why?
What are the Opportunities for Improvement (OFI) for Quality?
Overcoming Barriers to Receiving 510(k) Clearance: One Company's Go-to-Market Triumph
How to Select a Contract Manufacturer
A Regulatory Gap Analysis of FDA's Systems & Policies
Greenlight Guru Acquires CanvasGT: A Fire(less)side Chat
Tips for Being Prepared Post-EUA (Emergency Use Authorization)
Understanding the UDI System for Medical Devices
Shaking Things Up: What's Next for the Global Medical Device Podcast
How Augmented Reality (AR) is Revolutionizing Healthcare
Why FDA is Prioritizing Clinical Decision Support Software & Why You Should Care
A Special Glimpse into Medtronic's Recent Developments in Spine & Biologics Technology
What are the Top Compliance Issues Plaguing Medical Device Manufacturers?
Setting the Record Straight on Usability & Human Factors
Project Management for Product Development of Medical Devices
Assessing the Global Regulatory Landscape
Quality Insights from a 40+ Year Veteran of the Medical Device Industry
When to Throw the Least Burdensome Flag on FDA
Past, Present, Future State (and World) of Quality in the Medical Device Industry
Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc
Addressing the 'Who, What, When' of Quality in the Medical Device Industry
Why Storytelling Matters for Medical Device Companies
A Breakthrough Device that Aims to Prevent Osteoporosis
Understanding FDA's New Intended Use Rule and its Implications
eQMS in Academia: Practical Learning for Biomedical Engineering Students
Tips for Running Better Management Reviews
Navigating the MedTech Cybersecurity Ecosystem
Managing Clinical Data Activities
Explaining the Role of Importer under EU MDR
Preparing Your Pre-Submission with the Content FDA Wants to See
How RADx Tech II Program is Fast-Tracking COVID-19 Technologies to Market in 2021
How New Training Partnership is Advancing Medical Device Knowledge & Professional Development
Top 3 Most Cited Issues in Medical Device Inspections from FDA FY2020
How Mindset Training Can Help Your Team Operate at Peak Performance
Examining the HHS Proposal for Premarket Notification Exemptions
Crash Course on Greenlight Guru Academy: How Medical Device Professionals Stay Ahead
Building your Brand as a Medical Device Professional
Understanding the Value of a Medical Device Guru
Regulatory Tips & Pointers from a Former FDA Reviewer
Why Demand is so High for Regulatory & Quality Jobs (and should You take Advantage?)
Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program
Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?
Managing Business Risk as a Medical Device Company
Waterfall vs. Agile: Battle of the Product Development Methodologies
For the Love of Internal Auditing
Similarities & Differences Between In Vitro Diagnostic (IVD) Devices & Medical Devices
Knowing vs. Doing as Medical Device Professionals
Pivoting Operations to Meet PPE Demand During Pandemic
Pros & Cons of Being a Physician Turned MedTech Inventor
3 Systems of Risk for Medical Devices from FDA
Quality Management for IVD Devices vs Medical Devices
Understanding the Investigational Device Exemption (IDE) Process
Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry
Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients
What is the Safer Technologies Program (STeP) and Can Your Device Use It?
Why the PMA Process is so Dreaded by Manufacturers in the US Market
Building a Startup in the MedTech Industry
Visualizing a Medical Device through Illustrations, Animations, and other Artwork
Everything you Need to Know about SaMD from an FDA Perspective
Preparing for Remote and On-Site Inspections and Audits
How does EU MDR impact your Quality Management System?
Virtual Auditing in a Post-COVID World of Digital Compliance
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View
Prioritizing Medical Device Reimbursement During Product Development
5 Actionable Lessons Learned from the RADx Initiative by NIH
What are the Strategic Priorities for CDRH in 2021?
Understanding and Handling Different Types of Feedback
Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape
Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry
Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near
How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?
Why SaMD Companies Should be Leveraging Pre-Submissions to FDA
What Goes into Designing Devices for Military and Emergency Applications?
Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?
Positive and Negative Impacts of EUA on the Medical Device Industry
Why Biocompatibility Should be Addressed by Every Medical Device Company
What is a Multiple Function Device?
Challenges related to Home Use Devices
Submitting a 510(k) using FDA's Safety and Performance Based Pathway
How Jon Speer Met His Most Frequent Guest: Mike Drues
What are the Audit Etiquette Rules I Should be Following?
Addressing Clinical Trial Challenges & Concerns during COVID-19
Protecting the Intellectual Property of your Medical Device Technology
How to Build a QMS for a Medical Device
What is Regulatory Due Diligence for Medical Devices?
Mass-Manufacturing a 5-in-1 Ventilator System for COVID-19 Relief
How Being Strategic During A Career Transition Can Yield The Best Opportunities
Identifying the Positive and Negative Effects of COVID-19 on the Medical Device Industry
How to Construct an Effective Regulatory Strategy
What you Need to Know about Clinical Evaluation & Validation for Software as a Medical Device (SaMD)
How to Use Artificial Intelligence & Machine Learning to Produce Better, Smarter, Safer Devices
510(k) Tips and Answers to Frequently Asked Questions for Medical Device Companies
Addressing the PPE Shortage with a No Cost Solution for Healthcare Providers
[LIVE] How EU MDR Changes are Impacting the Medical Device Ecosystem
How to Approach Verification and Validation for Cloud Software
Fighting COVID-19: How one MedTech Company is Using UV-C Technology to Eliminate Virus & Save Lives
Emergency Use Authorization (EUA) 101: What Medical Device Companies Need to Know
How to Integrate Usability into your Medical Device
[LIVE] Design Controls, Development, and Risk for Software as a Medical Device (SaMD)
How to Leverage IEC 62304 to improve SaMD Development Processes
What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?
How to Choose the Right FDA Regulatory Pathway for your Device
How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory
4 Parts to Interviewing Candidates for Medical Device Roles
5 Tips for Hiring Medical Device Advisors
2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020
Navigating the Twists and Turns of Change Management for Medical Devices
What Is FDA's ASCA Pilot Program And How Does It Impact Medical Device Manufacturers?
5 Myths about QA/RA Recruiting in the Medical Device Industry
How to Solve the Medtech Value Equation with Quality Data
Why Supplier Quality Management Is So Important
FDA is Expanding its Case for Quality Program... Should Your Company Participate?
Addressing Top Questions of QA/RA Candidates on Salary, Skill Sets and Job Satisfaction
Is FDA's New 'Safer Technologies Program' Applicable To Your Medical Device?
Understanding the Benefit-Risk Determinations of FDA's Latest Guidance Documents
Leveraging Technology and Rapid Prototyping Methodologies during Product Development
Why Design Verification Matters in Medical Device Design and Development
Implementing Changes to SaMD under New EU MDR
Career Tips for QA/RA Professionals in the Medical Device Industry
Challenges with Pediatric Medical Devices
How General Wellness Devices Have Opened a Pandora's Box of Confusion
Regulating Artificial Intelligence and Machine Learning-Based Software as a Medical Device
Importance of Software Requirements in Product Development
4 Facts That May Surprise You About FDA
Design History File Ready Ideation: An Innovative Approach to Product Development
Looking at the Sunset of FDA's Alternative Summary Reporting Program
Challenges with MedTech Innovation
Is Your Medical Device Company CAPA Happy?
Integrating Human Factors into Design Controls to Improve Patient Outcomes
Greenlight Guru In the Classroom: A University's Real-world Approach
EU MDR: Not All Doom and Gloom
Biocompatibility Nuances and its Impact on Medical Devices
How to Make De Novo a Viable Option for your Medical Device
The 100th Episode: A Few of My Favorite Moments
Live Atlanta True Quality Roadshow Panel: The Changing Quality & Regulatory Paradigm
Grasping the Impact of Artificial Intelligence and Machine Learning on Medical Devices
Modernizing 510(k) Program through new FDA Safety and Performance Based Pathway
Nonbinding Feedback is a New Guidance You Should Know About
How and When to Consider Human Factors
Design Validation vs. Human Factors Validation
Medical Device Product Development Value Proposition
Why You Should Fear Product Liability Attorneys More Than Regulatory Agencies
Quality Systems Management (QSM) vs. Quality Management System (QMS) - What's The Difference?
Aligning True Quality and Compliance with MDDAP
Explaining the Significance of Voluntary Consensus Standards
Medical Device Industry Predictions for 2019
FDA Plans to Modernize 510(k) - Is the Sky Falling?
Understanding the Blurred Lines Between Consumer Tech and MedTech
Understanding The Differences Between Clearance vs Approval vs Granted
Streamlining The Device Marketing Authorization Process
The New Special 510(k): What You Need To Know
How to Efficiently Raise Funds for Your Medical Device Company
7 Habits of Highly Effective True Quality Medical Device Professionals
Regulatory Tips & Strategies from a Former FDA Reviewer
Questions to Ask Before Hiring Your QA/RA Consultant
What You Need to Know About The FDA CDRH Experiential Learning Program
Latest Updates on CDRH Standards Program and IEC 60601
15 Habits of Highly Effective Regulatory Professionals
How to Embrace Risk for Safer Devices
What you need to know About FDA’s Progressive Programs
What Are the Regulatory Expectations for Software as a Medical Device (SaMD)?
The Bleeding Edge: Lessons Learned for the Medical Device Industry
AI Explainability: What that Means and Why it Matters in the Medical Device Industry
How Human Factors Impact Your Medical Device
How to Think About Quality and Regulatory as Your Company Scales
How to Design for Compliance with IEC60601
FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?
How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage
Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)
Tips, Tricks & Best Practices for Complying with ISO 13485:2016
Helping to Prepare Biomedical Engineers Entering the Workforce
How to Ensure Your Quality Management System is Effective and Benefits Patients
CAPA Process Mistakes You Want to Avoid
How to Determine the Operational Quality of a Quality System Using a Performance Assessment
What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's Important
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway
An Overview of What Medical Device Developers Need to Know About Human Factors
Challenges with Applying Risk Management Throughout the Manufacturing Process
Common Mistakes That Can Tank Your FDA 510(k) Submission
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions
Lessons to Be Learned from Recent FDA Inspections
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission
How Process Excellence Leads to Product Excellence
Understanding FDA’s Proposed Conformity Assessment Pilot Program
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device
Understanding the Connection Between Complaints, CAPAs, and MDRs
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device
The Intersection of Medical Device Usability and Risk Management
How FDA Interacts with Medical Devices When They Are Imported Into the US
An Overview of What Device Makers Need to Know About CAPA
How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
What Devicemakers Need to Know About Medical Device Reporting (MDR)
How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan
2016 Medical Device Regulatory Trends Year in Review
Using the Bucket Method for Medical Device Risk Management
Tips for Success When It Comes to IEC 60601 with Leo Eisner
Understanding the New FDA Guidance on Changes to a 510(k)
What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)
Preparing for the Changes to the EU Medical Device and In-ViTRo Diagnostics Regulations
Tips for Avoiding Problems with the First-In-Human Study Process
Tips & Pointers for Effective Internal Quality Audits with Kyle Rose
How to Properly Use the FDA Pre-Submission Process and Why It's So Important
Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development
Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner
Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?
Tips to Help You Prepare for an FDA Inspection
What Device Makers Need to Know About Design Verification and Validation with Mike Drues
Why Integrating Business Elements into Your Medtech Development Process Is So Important
How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso
Medical Device Product Development Project Management Best Practices with Peter Sebelius
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner
Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor
Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey
How To Avoid Major Common Mistakes During the FDA 510(k) Process with Michael Drues
Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson
How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken
Risk Management from a Regulatory & Product Development Perspective [Podcast]
How To Improve Your Design Reviews (Bonus Episode)
How To Improve Your Medical Device Design Reviews
Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?
Best Practices for Implementing Design Controls for the Medical Device Industry
MedTech True Quality Stories Podcast
Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device
Elevating True Quality with SaMD for Early Cancer Detection and Treatment
A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP
Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections
Creating a Culture of Quality for Medical Device Companies
Improving the Colon Cancer Screening Experience
Advancing MRI Technology As We Know It Today
How a Shift in Mindset Resulted in a Higher Quality IQ for this Industry Veteran
Improving the Quality of Life in the Most Delicate Patient Group: Preterm Born Infants
How Sonavex Went from Concept to FDA Clearance in Just 3 Years
Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories
Press Releases
A Year of Scale, Support, and Celebration
Greenlight Guru Hits the 1,000 Customer Milestone
Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL
Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligence
Greenlight Guru Expands Solution To Further Integrate Quality And Product Development Activities
Greenlight Guru Announces True Quality 2022, Inaugural Conference For The Medical Device Industry
Customers Rank Greenlight Guru As Leading QMS Software On G2 For 13th Consecutive Quarter
Greenlight Guru Launches Guru Assist, On-Demand Lifeline To Medical Device Experts
Greenlight Guru Opens New Global Headquarters In Downtown Indianapolis
True Quality: Greenlight Guru Consistently Ranked The #1 QMS By Users For Three Years In A Row
CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition
Greenlight Guru Announces Medical Device HQ Partnership
Greenlight Guru Receives Strategic Growth Investment From JMI Equity
Greenlight Guru Launches Global Medical Device Job Board
Greenlight Guru Announces the Formation of its New Regulatory Advisory Board
Greenlight Guru Named Premier QMS Software for NIH RadX Initiative
Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR
Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit
Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events
Greenlight Guru and EMERGO by UL Announce Strategic Alliance
Greenlight Guru Announces Enhanced Change Management Capabilities
Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams
Greenlight Guru Announces New Integration with Jira Software
Greenlight Guru Announces Advanced Document Management
Greenlight Guru Announces Multi-Level Design Control Software
Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes
Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016
Greenlight Guru Wins 2015 Indiana Innovation Award
Free Downloads
Quality Event Template Package for CAPAs, Complaints & Nonconformities
Clinical Evaluation Procedure Template
Checklist to Evaluate Your Quality Control Process
Design Transfer to Manufacturing
Medical Device Reporting (MDR) Decision Tree
How To Prepare An FDA Pre-Submission
Periodic Safety Update Report Template
Abbreviated 510(k) Submission Checklist
Checklist For Selecting Suppliers + Contract Manufacturers
FDA Labeling Requirements Checklist
Checklist: Premarket Submission Documentation For Devices Containing Software
Checklist for Structuring Your Technical Documentation
Approved Supplier List Form Template
Clinical Investigational Report Checklist
Content Toolkit for Medical Device Startups
MDR & IVDR Gap Analysis Toolkit
5 Steps for Creating a Traceability Matrix
510(k) Program Comparison Chart
Total Quality Management 4-in-1 Tool
Legacy vs Best-in-class QMS Tools Comparison Chart
Change Impact Analysis Template
Nonconformance Report Template
Free Replay Package: 2021 Medical Device Virtual Summit
Checklist: 7 Steps to Comply with FDA 21 CFR Part 11
Value of True Quality Infographic
Top 100 Medical Device Startups with Most Money Raised in 2020 Chart
Biocompatibility Testing Selection Criteria
Human Factors & Usability Engineering Report
7 Steps for Writing a Nonconformance Report
3 Tips for Receiving EUA from FDA
10 Ways a Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead
MDD vs. MDR Gap Assessment Tool
5 Myths About PMA's (And What's Actually True)
Content Toolkit for Medical Device Executive Leaders
Content Toolkit for Medical Device QA/RA Professionals
Content Toolkit for Medical Device Product Developers
EU MDR: SAMD Guidance Document + Audit Gap Assessment Tool
21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes
Product Requirements Guide + Checklist with Writing Tips
MDSAP vs. ISO 13485:2016 Gap Assessment Tool
Suggested Quality Domain Metrics
Compliance or Quality Focused Comparison Chart
What Influences SAMD Classification?
Benefits of a Formal Document Management Solution
5 FDA 510(k) Submission Mistakes to Avoid
What Medical Device Investors Want to See Checklist
4 Cornerstones of an Effective EQMS
6 Ways AI is Transforming Healthcare
Top 100 Medical Device Companies in the World Chart
5 Practical R&D Tips for Medical Device Developers
Key Questions for Defining User Needs
7 Tips for Incorporating Human Factors into Device Design
Tips to Building Consistent QMS Procedures
5 Tips for a Competitive Regulatory Strategy
5 Tips for Better DHF Management Cheat Sheet
Most Common Sources of Post-Market Surveillance Data
15 Steps to Create a Risk-Based CAPA Process Infographic
Ultimate List of Medical Device Incubators & Accelerators
4 Steps to Gathering Accurate Complaint Data
Overview of a Customer Complaint-Handling Procedure
Guide to When to Use Different Tools for CAPA Analysis
FDA 483 & Warning Letter Checklist
Cheat Sheet on Preparing Your Team for an FDA Inspection
7 Signs You're Ready for an EQMS
5 Ways to Prepare Your Team for an FDA Inspection
Using Your 510(k) Submission for Design Controls and DHF Table
5 Tips for Using a Predicate Device
4 Signs You Need to Issue a CAPA
Key Elements of Your Design History File Checklist
10 Resources to Get Medical Device Companies on Track
5 Key Steps for Getting Your Medical Device CE Mark
Sample Management Review Template
Tips to Help Define User Needs
4 Helpful Tips for Better Management of Your Design History File
9 Tips for Password Compliance with 21 CFR Part 11
4 Reasons the Root Cause isn't "User Error" Cheatsheet
What FDA Expects to See as Part of Your CAPA Process Cheatsheet
5 Step Checklist to Determine if a CAPA is Required
Checklist for Selecting Suppliers to Your Medical Device Company
4 Methods for Root Cause Analysis Cheat Sheet
7 Rules for Effective Medical Device Design Controls Cheat Sheet
5 "Whys" for Root Cause Analysis Technique Cheat Sheet
5 Tips for a Successful 510(k) Submission
8 Quick Facts about CAPA Cheat Sheet
ISO 13485:2016: Changes You Should Know About
ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table
Failure Mode Effects Analysis (FMEA) Template
Medical Device Product Development Checklist
FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist
FDA 483/Warning Letter Response Template
5 Tips to Help Your FDA 510(k) Submission
How to Plan a Clinical Data Management Setup for EDC Systems
Ultimate Guide to Device Class Requirements under EU MDR
How to Design an Electronic Case Report Form (eCRF) for Medical Device Studies?
How to Calculate Sample Size for Medical Device Studies
Ultimate Guide to Supplier Management for Medical Device Companies
Ultimate Guide to UDI for Medical Devices
Selecting The Ideal PMCF Activity
Ultimate Guide to Software as a Medical Device (SaMD)
Ultimate Guide To Clinical Evaluation Of A Medical Device In The EU
25 FAQs (& Answers) About ISO 15223-1:2021 Fourth Edition
Ultimate Guide to QA & RA in Medical Device 3D Printing
2021 EU MDR Preparedness Study
State of Medical Device Quality Management and Product Development Report
Ultimate Guide to Training Management for Medical Device Companies
Ultimate Guide to 21 CFR Part 820 — FDA's Quality System Regulation (QSR) for Medical Devices
Ultimate Guide to Document Control
The Definitive Guide to ISO 14971 Risk Management for Medical Devices
Best QMS Software: Ultimate Guide to Comparing Quality Management System Solutions
15 Questions to Ask QMS Software Vendors in the Medical Device Industry
Definitive Guide to Change Management for Medical Devices
5 Do's and Don'ts when Choosing a QMS Solution for your Medical Device Company
A Complete Guide to Bringing a Medical Device to Market
Ultimate Guide to Agile Design and Development for Medical Devices
The Essential Guide to Preparing your QMS for EU MDR
ISO 13485 - Ultimate Guide to the Quality Management System (QMS) for Medical Devices
15 Reasons Why Medical Device Companies Choose Greenlight Guru
21 CFR Part 11: A Complete Guide
Medical Device QMS Changes: How to Manage Changes Regarding EU MDR, IVDR & ISO 13485:2016
Why Paper-Based Quality Management Systems are No Longer an Option
A Step-By-Step Guide to Preparing Your FDA 510(k) Submission
The Art of Defining Design Inputs And Design Outputs
The Ultimate Guide To FDA Design Controls For Medical Device Companies
Ultimate Guide to Corrective and Preventive Action (CAPA) for Medical Devices
The Risk Management + Design Controls Connection
Definitive Guide to Responding to FDA 483 Observations & Warning Letters
Step-by-Step Guide to Complying with ISO 13485 & FDA QSR
15 Items Medical Device Startups Need to Address
Step-by-Step Guide to Determine How Your Device will be Classified
Guide to Design Verification and Design Validation
23 Must-haves for your Product Requirements Document (Free Checklist + Guide)
10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]
Why Flexible Design Reviews Matter for Medical Device Product Development
Best Practices for Effective Medical Device Design Reviews
FDA Case for Quality: 2018 Comprehensive Review
Pillar Pages
Webinars
5 Tips for Designing a Medical Device Study under US FDA Requirements
FDA Digital Health Updates: What changed in 2022 and what should you expect in 2023?
Regulatory Due Diligence: Why Pay for Information You Can Get for Free?
Monetizing Software: The Challenges of Commercialization & How to Overcome Them
Usability Testing: Why can’t we get it right?
Clinical Considerations for Software and Artificial Intelligence (AI) / Machine Learning (ML)
Connecting Computer System Validation to Daily Operations
How to Ensure Your State of Affairs for EU MDR is State of the Art
Considerations for Building Your Own Cloud Device: Regulations, Privacy & Cybersecurity
MDR Transition and Tech File Changes: What Medical Device Companies Need to Know
Integrating Cloud & Modern Computing Technologies into the Operation of Your Medical Device
Bridging The Gap Between Development And Regulatory Teams
How To Survive An FDA Inspection
Special Controls: What Are They & How Can We Use Them To Our Advantage?
How To Proactively Predict & Mitigate Risk Throughout The Supply Chain
Top Things You Should Know When Developing Software As A Medical Device (SaMD)
Key Pitfalls To Avoid In MedTech Clinical Data Collection
Letter-to-File 101: Are You Sure You're Preparing Yours Correctly?
Building Your BOM: 3 Ways To Manage Your Product Information With Full Traceability
UDI Product Data And EUDAMED Get Onboard!
How To Ace Your Internal Audits In 2022
How To Effectively Implement The New ISO 14971:2019 & Maintain Your Current Risk File
Breakthrough Device Designation & Its Impact On Reimbursement
The “New” 510k: How Do You Show Substantial Equivalence Without Using A Predicate?
Human Factors Engineering: The Worldwide Guide For Medical Device Manufacturers
Demystifying the Breakthrough Device Designation (BDD) & Safer Technologies (STeP) Processes
5 Key Points to Consider in Design Transfer of Medtech
FDA vs. EU Regulatory Pathways: Factors Every Startup Must Consider with Go-to-Market Strategy
How to Prepare for and Manage Audits/Inspections Across Global Markets
Evaluating Need for Biocompatibility Testing & Mitigating Risks When Changing Your Medical Device
How to Integrate Cybersecurity into Your Existing Medical Device Development Lifecycle
3 Ways To Transform Your Change Process Through Ai-powered Predictive Quality
Change Management And Risk Management: How Do We Connect The Dots And What Happens If We Don’t?
When Do We Need FDA’s Permission to Market Our Device and When Do We Not?
3 Powerful Ways to Revolutionize Your Approach to Closed-Loop Quality System Traceability
Best Tools & Tricks for Meeting IVDR Requirements to Obtain CE Marking
How to Implement and Maintain a Modern CAPA System While Avoiding Common Pitfalls
Verification & Testing Strategies for Compliance with ISO 13485:2016, IEC 62304 / 60601-1 / 82304-1
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device in the Coming Decade
Are You Sure You Know the Best Regulatory Pathway for Your New Medical Device?
How to Use UX to Streamline Medical Device Product Cycles
Key Considerations for SAMD Companies Developing and Commercializing Software as Medical Devices
Behind the Stats: Medical Device Product Development & Quality Management Benchmark Survey
Beyond Design Controls 101: Following the Regulation vs. Understanding its Intent
Implementing Best Practice Medical Device Change Control Processes (While Avoiding Common Pitfalls)
An Exclusive Look at the New Changes to ISO 14971:2019 and ISO TR 24971:2019
How and When to Start Documenting Your Formal Design Controls With DHF Ready Ideation
How and When to Register EU Medical Devices and Report UDI Information to EUDAMED
How to Apply Risk Management Throughout the Product Lifecycle of Your Medical Device
10 Steps to Preparing Your 510(k) Submission (And How to Avoid the Common Pitfalls)
Breakthrough Designation Program: Is this an Option for My Medical Device?
Quality Leaders' Playbook for Driving Executive Engagement with Quality Systems
Why Design Validation is More than Testing: How Do We Validate Our Validation?
Understanding Post-Market Surveillance Under EU MDR: Being Proactive, Not Reactive
Why User Needs Matter & Their Benefits in Streamlining Device Design and Development
How to Avoid Common Problems With Your Design, Risk, and Validation Documentation
When Design Input Requirements Go Wrong
EU MDR: How Do I Interpret the New Regulations and What Do I Need to Do to Be Compliant?
FDA Partners With Greenlight Guru: Case for Quality Webinar Series
The 510k and Substantial Equivalence: Why Do So Many Get it Wrong?
5 QMS Elements that Must Connect to Your Design Control for an Effective, Audit Proof Process
Standards, Standards, Standards – Makes the Medical Device World Go Around
How to Conquer Supplier Management for Medical Device Companies
FDA's Case for Quality: Non-Product Computer System Validation (Part 4 of 4)
Quality vs Compliance Metrics & What's Next for FDA's Case for Quality Pilot (Part 3 of 4)
The Pre-Market Approval (PMA): Is it Really as Bad as so Many Think?
FDA's Case for Quality: Voluntary Program and Status Update (Part 2 of 4)
10 Things You Must Know About Updating Your Technical Files to Comply With EU MDR
FDA's Case for Quality: What, Why and How? Changing the Regulatory Paradigm
Bridging User Needs & Design Requirements
A Timeline to Comply With ISO 13485:2016 (And What You Need to be Doing Today)
General Wellness Devices & Wearables: Regulatory Options You Need to Know
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)
Regulatory Intelligence (Mis)management in the Medical Device Industry
How Software Can Be Leveraged to Streamline Device Development
Demystifying the FDA's Human Factors Guidance
What You Need to Know About Medical Electrical Standards Updates
Advanced Strategies and Tactics for Using the De Novo Pathway
How Design Controls & Risk Management Best Practices Reduce Customer Complaints & CAPAS
Best Practices for Medical Device Change Management
How to Create a Risk-Based CAPA Process
Top 10 Most Significant Changes Introduced by the New EU MDR
How to Prepare for the Medical Device Single Audit Program (MDSAP)
How QMS Software can Speed Up Your Product Development & Simplify Compliance
How to Prepare for a Successful Design Transfer
How to Prepare for (And Make the Most of) Your FDA Pre-Submission
Many Connotations of Risk in Medical Device Development
What You Need to Know About Life with FDA after Your Device Gains Clearance
5 Things the Medical Device Industry Should Expect in 2017
15 Steps to Get Approval to IEC 60601-1
8 Steps to Implement an EU-MDR Compliance Program
How to Prepare for the New EU Medical Device Regulations (MDR)
How to Simplify Your Compliance to the New ISO 13485:2016
How to Prepare for the New EU In Vitro Diagnostics Regulations (IVDR)
510(k) Submission Tips, Tricks & Timlines from a Former FDA Reviewer
Medical Device Project Management Best Practices
Clinical Evaluation in the EU for Medical Devices
How to Avoid and Respond to FDA 483's and Warning Letters
Everything Device Makers Need to Know About Design Controls
An Overview of ISO 14971 Risk Management
Understanding the Changes to ISO 13485:2016
How to Prepare for the Transition to ISO 13485:2016
How to Manage & Mitigate Risk in New Product Development
Original Research Reports
2022 State of Medical Device Report
Events
The Future of QMS Requirements True Quality Summit Series
Global MedTech Regulatory Trends: True Quality Summit Series
Raising Capital True Quality Summit Series
Get To Market True Quality Summit Series
Risk Management True Quality Summit Series
Get To Market True Quality Summit Series
EU MDR & IVDR True Quality Summit Series
2021 State of Medical Device Virtual Summit
The Greenlight Guru True Quality Virtual Summit
Press Mentions
Greenlight Guru Earns ISO 9001 and ISO 27001 Certifications
Greenlight Guru earns ISO 9001 and ISO 27001 certifications
Greenlight Guru receives ISO 9001 and 27001 certification
Best Tech Companies to Work For
Greenlight Guru Unveils Medtech Lifecycle Excellence Platform
Greenlight Guru acquires SMART-TRIAL
Greenlight Guru acquires SMART-TRIAL
Tech firms grow wary as funding streams slow
Greenlight Guru Acquires Smart-Trial
Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL
Local tech firm Greenlight Guru acquires Danish firm
Greenlight Guru Acquires Vertex Intelligence
Greenlight Guru Acquires Zionsville Company
Greenlight Guru Acquires Vertex Intelligence
How downtown Indy tech companies plan to move forward from the pandemic
The Midwest’s Best Enterprise Software Companies
5 Thoughts on Harmonization of Quality Regulation
Case study: Building a partner ecosystem to beat opioid withdrawal
Greenlight Guru & Reed Tech Announce Alliance for Quality Management System Innovations
Report sheds light on views on quality management
Third of pre-market companies still use general purpose tools - report
Chamber Names ‘Best Places to Work’
Greenlight Guru Launches Medical Device Product Development Platform
Greenlight Guru launches workspace for product development control
Greenlight Guru launches new product development workspace
Best Places to Work 2022: Mid-Sized Startups
A fast-growing software company will expand to the Triangle after buying Raleigh startup
Greenlight Guru Acquires Software Company CanvasGT
Greenlight Guru Acquires Medical Device Software Firm
Greenlight Guru acquires CanvasGT in aim to enhance research and design
Greenlight Guru acquires design solution provider CanvasGT
The time has come to remove “emerging” from the description of Indiana as a major tech hub.
Top Midwest Startup Funding Rounds in 2021
Indy Startups Featured on ‘Tech Companies to Watch’ List
Top Indianapolis Tech Companies and Startups to Watch in 2022
Greenlight Guru Launches On-Demand Guru Assist
Some firms have nixed the office; others are doubling down
Formlabs Partners With Greenlight Guru For High Quality Product Development
Formlabs and Greenlight Guru partner to accelerate the development of medical devices
Formlabs announces medical device partnership with Greenlight Guru
2022 Indianapolis Companies with the Best Benefits
How to manifest success through mindset training
Greenlight Guru to Open New HQ
Greenlight Guru Celebrates New, Larger Downtown Offices
2022 Best Tech Startups in Indianapolis
Medical Devices And Mindset Training: Greenlight Guru
VIDEO: Greenlight Guru CEO talks about $120 million investment from JMI Equity
Greenlight Guru Partners with Cybersecurity Firm
Greenlight Guru Announces Medical Device HQ Partnership
JMI Equity invests $120M in Greenlight Guru
Greenlight Guru receives $120m investment
CEO: Greenlight Guru Found Right Partner for Big Investment
Indy-based software firm receives massive $120M investment to foster growth
Greenlight Guru Lands $120M Strategic Investment
Software-Focused JMI Equity Invests More Than $120 Million in Greenlight Guru
Finding Success, Growth And Wellness Through Self-Hypnosis And Mindset Training
Greenlight Guru launches Global Medical Device Job Board
Global Medical Device Job Board launches today
Greenlight Guru forms Regulatory Advisory Board
12 Midwest Startups offering Mental Health Benefits
Why this Software Company Rewards Employees who get the Best Sleep
NIH Selects Greenlight Guru as the Premier QMS for the RadX Tech Program
Greenlight Guru to Provide QMS to NIH Diagnostics Program
Indy Company Selected for National Covid Testing Program
Greenlight Guru Partners with NIH RadX Program to Improve COVID-19 Testing
Education and Training for Medical Device Professionals
Greenlight Guru Launches Greenlight Guru Academy
Academy Launched for Medical Device Development
Virtual Summit to Help Understanding of New EU Regulations
Greenlight Guru Announces True Quality Summit Series
Greenlight Guru and Nelson Labs Strategic Alliance
Greenlight Guru Partners with Global Laboratory Testing Firm
Greenlight Guru to Collaborate with Nelson Labs
Greenlight Guru and Nelson Labs Partnership Aims to Get Products to Market Quicker
Greenlight Guru, Nelson Labs Form Strategic Alliance
Greenlight Guru to Collaborate with Nelson Labs
'State of Medical Device' Shows Gap
QMS Platform Release State of Medical Device Report 2021
Greenlight Guru Release Findings of State of Medical Device Report 2021
Survey Finds On-Site Inspections Plummeted by 93 Percent
Greenlight Guru Launches Training Management Workspace
Greenlight Guru Launches Training Management Software
Greenlight Guru Announces State of Medical Device Virtual Summit
Greenlight Guru Launches Quality Event Automation Service
Greenlight Guru Launches Quality System Tracing Software
Greenlight Guru Launches New Ml Closed-Loop Traceability Tool
QMS Software Platform Launches New Tool for Closed-Loop Traceability
Greenlight Guru Relaunches Programme to Enable Faster Access to Market for Medical Devices
IndyStar Top Workplaces 2020: Greenlight Guru
Greenlight Guru to Host a Three-Day Virtual Event
Greenlight Guru Announces the True Quality Virtual Summit
Greenlight Guru, Emergo by Ul Tout New Software Package
Greenlight Guru Announces Partnership to Simplify Global Market Access for Medical Device Companies
Greenlight Guru and Emergo Announce Quality Management and Regulation Tie-Up
Greenlight Guru Updates Risk Management to Align with ISO 14971:2019
Tech Community Steps Up to Help Indiana Respond to COVID-19
On the Road Again: Greenlight Guru True Quality Roadshow
Dublin Added to True Quality Roadshow
Greenlight Guru Hits the Road Again
Greenlight Guru Takes Roadshow International
Greenlight Guru Updates Change Management Capabilities of QMS
Greenlight Guru Announces Enhanced Change Management Capabilities
Does Your Organisation Ensure Compliance and Promote Quality?
Survey Identifies Challenges to Improving Product Development Processes
Survey: 75% MedTech Pros Unprepared for an Unannounced FDA or Notified Body Audit
Powderkeg Tech Culture Awards Spotlight on Greenlight Guru
Choosing the Right QMS for Your Medical Device Company
Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams
Best Places to Work in Indiana for 2019
Greenlight Guru Receives 3 Nominations at 2019 Mira Awards
Hand-In-Hand with Quality and (Regulatory) Changes
Greenlight Guru Takes its Show on the Road
Greenlight Guru Announces Nationwide Medical Device Quality & Regulatory Roadshow
Out-Of-State Firms are Sweeping Up Indiana’s Tech Startups. Is that a Good Thing?
Alphabet’s Health Division Gets FDA Clearance to Test EKG Smartwatch Feature
Best QMS Software for Small Manufacturing Businesses
Greenlight Guru Recognized by G2 Crowd for QMS Capabilities
G2 Crowd Names Greenlight Guru as Sole Leader in Quality Management Software Category
Digital Medicine Set to Boom in 2019, Say Experts
Apple Watch Electrocardiogram and Irregular Heart Rate Features are Available Today
Greenlight Guru Announces New Integration with Jira Software
Greenlight Guru Integrates with Jira Software
How Smart are Your Design Inputs?
Medical Device Solutions Firm Greenlight Guru Integrates with Jira
Greenlight Guru Announces New Integration with Jira Software
Greenlight Guru Announces New Integration with Jira Software
How the Apple Watch Changed the World
Greenlight Guru Announces New Integration with Jira Software
Tech Talk: Can You Use a Few More Workers?
Supplier Stories for the Week of September 30
Greenlight Guru Hires Brent Atwood, 25 Year Medical Device Industry Veteran
Greenlight Guru Hires 25 Year Medical Device Industry Veteran
Apple Watch Series 4 Review: The Best Watch Gets Better
Apple Watch Series 4 ECG Detects AFIB at More than 98% Accuracy, is “Cleared” by FDA, Not “Approved”
What the Apple Watch’s FDA Clearance Actually Means
FDA: Case for Quality Collaboration
Greenlight Guru Maintains Transparency in Medical Device Development
Greenlight Guru Announces Advanced Document Management
Greenlight Guru Announces Advanced Document Management
Greenlight Guru Announces Advanced Document Management
Medical Device Companies Put Greenlight Guru in Fast Lane
New Podcast: AI Explainability
Quality Management Software Maker Greenlight Guru Takes Pride in Doing the Hard Things
Greenlight Guru Continues Momentum with Sustained Quarter Over Quarter Growth
Greenlight Guru Shows Continuous Growth in First Half of 2018
Greenlight Guru Continues Momentum with Sustained Quarter Over Quarter Growth
Hiring for New and Emerging Tech Fields
Supplier Stories for the Week of July 8
Greenlight Guru and FDA to Present Case for Quality Webinar Series
FDA and Greenlight Guru Announce Case for Quality Webinar Series
Supplier Stories for the Week of May 20
Greenlight Guru’s Multi-Level Design Control Software
Greenlight Guru Launches New Software, Growing Team
Greenlight Guru’s Newest Software Version Enhances QMS, Complex Design Tracking
Greenlight Guru Announces Multi-Level Design Control Software
Alligator Blood is the Key to Your Startup's Success
Greenlight Guru and Pathwise Announces Joint Training Event in Switzerland
People > Processes: A Conversation with Jessica Mcqueen, Account Executive at Greenlight Guru
Why I Only Hire People with 'Alligator Blood'
Design Insights and Lessons from the Workshops at MDTX
Will Regulatory Transitions Cause Some to Change Course?
Understanding QMS Software Validation Requirements in ISO 13485:2016
1-On-1 Interview: Untangling Medical Device Compliance
Mira Award Nominees Cover Tech's Wide Spectrum
Nominees Announced for TechPoint Mira Awards Honoring ‘The Best of Tech in Indiana’
'Best Places' in Indiana Reaches Record
Employer Success: Greenlight Guru
6 Strategies for Rebranding Your SaaS
Webinar: Where Should Medical Device Companies Launch Products First?
Greenlight Guru Growing Quickly Making Software for Medical Device Makers
Greenlight Guru Revenue Rockets in Q4, Plans Hiring Spree in Q1
Greenlight Guru Continues to Write Growth Story
Good-Bye, Fluffy Office Perks, and 3 Other Tech Business Predictions for 2018
Take Advantage of these 4 Midwest Tech Trends to Grow Your Business in 2018
Supplier Stories for the Week of November 12
Union 525 is Indy’s Newest Rallying Point for Tech Growth and Talent
Greenlight Guru Extends Platform with New Product to Streamline Post-Market Quality Processes
Greenlight Guru Adds Grow to Quality Management Software Platform
Greenlight Guru Extends Platform
Greenlight Guru Extends Platform with New Product, Grow, to Streamline Postmarket Quality Processes
Fanatical Support: David Deram’s 7 Tips for Motivating Your Team
Greenlight Guru Extends Platform with New Product, Grow, to Streamline Postmarket Quality Processes
Greenlight Guru Extends Platform with New Product, Grow, to Streamline Postmarket Quality Processes
Software Solution Streamlines Post-Market Quality Processes
Greenlight.Guru Closes Record-Breaking Third Quarter
Greenlight.Guru Continues Explosive Growth with Record-Breaking Rise in Revenue
Greenlight.Guru Continues Explosive Growth with Record-Breaking Rise in Revenue
Greenlight.Guru Continues Explosive Growth with Record-Breaking Rise in Revenue
Tech Companies Take Top Honors at Spaces Indiana Office Design Showcase
Steve Jobs isn't the Only Visionary Role Model--Look to these Entrepreneurs as well
How a Fearless Startup is Taking on Under Armour and Nike
How Medical Device Risk Management is Connected with Design Controls
24 Books Successful People Read
Why the Current Health Care Landscape is a Golden Opportunity for Tech Founders
The Top 4 Startup Secrets when Bootstrapping a New Product
Jobs in Tech Report: Q2 2017 Jobs Announcements in Indiana Technology Companies
Midwest Tech Entrepreneurs are Cashing in on a Golden Opportunity
Greenlight.Guru Hopes to Empower Innovative Medical Device Companies with Modern EQMS Software
After Steady Growth, Greenlight.Guru Plans New Office, More Hires
50 Best Must-Read Medical Device and MedTech News Sites, Blogs
Tech Company Sees 'Fast Rise' in Indy
Medical Device Software Firm Plans to Add 120 Jobs
Med Tech Company Growing in Indy
Greenlight.Guru Expands Indianapolis, Indiana, Operations
Mira Award Nominees Cover Wide Range
Greenlight.Guru Targets Growth in Asia
greenlight.guru Pitches New Medical Device Risk Management Software
Centric Names Innovation Award Winners
Health Tech Startup greenlight.guru Secures $1.25MM, Launches QMS Software
New Quality Management Software Designed Specifically for Medical Devices
Investment Spurs Tech Startup's Growth
How to Free Yourself from a Quality System Nightmare
Health IT Business News Roundup for the Week of February 20, 2015
New Quality Management Software Helps Medical Device Companies Get to Market Faster
Green Light for Cloud-Based Quality Management Software Designed for Device Industry
greenlight.guru Closes $1.25M Seed Funding
greenlight.guru’s QMS Helps Medical Device Companies
A Software Support System for Medical Device Developers Nets $1.25M in Fresh Capital
#nowtrending: This Week’s MedTech News
How the Smart Orthopedic Companies are Hacking FDA and ISO Compliance
Simplify Your Quality Management System
Thought Leadership Articles
Three things medtech firms need to do for 'true quality'
Top Hiring and Recruiting Tips for Med-Tech Companies
True Quality Experts Weigh in on MedTech Future Trends
Finding from Greenlight Guru's Benchmark Survey of 519 Medtech Professionals
Supplier quality management: What medtech manufacturers need to know
Three Lessons from True Quality 2022
Three Things You Need to Know About FDA QSR and ISO 13485 Harmonization
Three Ways To Know Your Medical Device Start-Up Is Ready For Your Next Round of Funding
4 Red Flags Investors Look For When Vetting Your Medical Device Company
Risk Management for Medical Devices
EU MDR Preparedness: How Is COVID-19 a Factor?
How an MDQMS Can Lead to More Efficient and Sustainable Diagnostic Tests
Closed-Loop Traceability for FDA Compliance
What are the Biggest Changes Under EU MDR?
Using Quality as an Advantage in 2021
Three Reasons Automation and Training Are Essential in Your MDQMS
What Is Quality Culture and Does Your Company Have It?
Why You Must Have a Single Source of Truth for CAPA
Expert Roundup: Achieving Success in the 2021 Medical Device Landscape
Imagine it’s 2030: What was the Key to Business Success During COVID-19?
Traceability Requirements in EU MDR
Four Essential Processes in Medical Device Risk Management
Adopting a Data-Driven Approach to Quality with an MDQMS
The Importance of Managing and Controlling Risk in the Medical Device Industry
Why I Left a MedTech Manufacturer for a Software Scale-Up
Areas to Consider in Medical Device Risk Management
Ensure Success Throughout the Entire Medical Device Lifecycle
What Consumer Tech Companies Need to Know About Medical Devices in the European Union
From the Experts: Best Practices to Ensure Device Success
Best Practices for Leading Medical Device Teams During the COVID-19 Pandemic
Managing and Leading Medical Device Companies and Teams During the Pandemic
COVID-19’s Impact on the MedTech Industry: How to Get Through
What You Need to Know for an Effective Risk Assessment
What Consumer Tech Companies Need to Know About Medical Devices in the US
Engineers: How to Curb Quality Myths Now
Building a MedTech Firm on a Foundation of Quality
Paper Processes: Three Reasons it’s a Costly Business Move
4 Powerful Ways Mindfulness Encourages Peak Performance
Why Great Companies Don't Run on Spreadsheets
3 Keys to Attracting Investors and Raising Funds for Your Med Device
Six Mistakes to Avoid When Implementing ISO 13485
5 Tips to Raise Funding for Your Medical Device
5 Tips to Raise Investor Interest and Fund Your Medical Device
4 Keys to Funding Your Medical Device
We’re Going Through Changes: Major Upcoming Regulatory Changes for Manufacturers Explained
Top 3 Mistakes You Can Make When Adopting ISO 13485
A Tsunami of Regulatory Changes is Coming
Top 4 Mistakes When Implementing ISO 13485
Five Tips From MedTech Executives on the Value of Quality
The Essential Guide to Preparing Your QMS for EU MDR
Not All Medical Device QMS Solutions are Created Equal
Quality is the Heartbeat of Your Company
Qualifying Your Suppliers Using a Risk-Based Approach
Choosing the Right QMS for Your Medical Device Company
The Most Common Problems With Your CAPA Process
What to Expect During an FDA QSIT Inspection
Top 26 Medical Device Conferences to Attend in 2019
6 Best Practices for Complying with ISO 13485:2016
Why Paper-Based Systems No Longer Make the Cut
5 Tips for Post-Market Medical Device Compliance
Why Cloud Software Companies Should Build for Vertical Industries
5 Reasons Design Controls and Risk Management Processes Fail
Cloud Companies Should Build for Vertical Industries
How to Avoid a MedTech Document Scavenger Hunt
Five Common Mistakes Companies Make with CAPA
Why the FDA Presubmission is an Underutilized Tool
A Timeline to Adopt Medical Device QMS (And Why You Need to Act Now)
How to Structure Your Internal Audit Program
Here’s What You Need to Know About FDA’s New Guidance on Software as a Medical Device
How to Streamline the Customer Complaint Handling Process
The Impact of Risk Management on CAPA
The Countdown to Implementing ISO 13485:2016
Greenlight Guru Revenue Rockets in Q4, Plans Hiring Spree in Q1
How to Integrate Complaint Handling and Risk Management
5 Things to Address if You’re a Medical Device Startup
What Should Really Trigger a CAPA?
Why the Best Engineers are Attracted to Big Problems
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)
The Potential Impact of FDA’s Use of Pro to Assess Effects of Medical Devices
How CAPA Connects to Other QMS Processes
5 Tips For Medical Device Engineers on FDA Design Controls
The 5 Most Common Problems With Your CAPA Process
Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Design Validation vs. Clinical Evaluation: What's the Difference?
How to Prepare Your Medical Device Company for an FDA Inspection
How to Define and Decode Your Design Inputs and Design Outputs
How to Define and Decode Your Design Inputs and Design Outputs
7 Common Mistakes that Sink FDA 510(k) Clearance
How to Debunk the Most Common CAPA Myths
Proper Design Controls Could Save You $20 Million
Why Your Medical Device QMS Should Match the Size of Your Company
15 Startup Secrets You Can Steal from Sports Cultures
How to Prepare Your Design History File for an FDA Inspection
Debunking 8 Commonly Held CAPA Myths
Medical Device Product Development: Pitfalls You Need to Avoid
Medical Device Product Development: 7 Pitfalls You Need to Avoid
Four Ways to Build an Elite Team (On or Off the Field)
What are the Best Ways to Handle Medical Device Customer Complaints?
What Should Trigger a CAPA in Medical Device Manufacturing?
Correcting Misconceptions about FDA Design Controls for the Medical Device Industry
Why You Must Know the Difference Between 'Intended Use' and 'Indications for Use'
4 Key Compliance Issues for Medical Device Companies
Five Tips for Medical Device Engineers on FDA Design Controls
5 Predictions for the Medical Device Industry
Key Challenges for Risk Management in Medical Device Development
3 Tips for Managing Your Medical Device Design History File
4 Reasons Your 510(k) Submission Will Be Rejected (And How to Avoid Them)
3 Tips to Reduce the Chance of a 510(k) Submission Rejection
Six Tips to Make Sure Your 510(k) Submission is Accepted
6 Tips to Reduce Likelihood of a Rejection for an FDA 510(k) Submission
4 Tips for a Smooth 510(k) Submission Process
ISO 14971 or FMEA: Which Should You Use?
First-In-Human Studies - What's the Rush?
Debunking 4 Commonly Held Design Control Myths
Eight Reasons Why Your Design Controls and Risk Management Processes Fail
Understanding ISO 14971 Medical Device Risk Management
3 Tips for Applying Risk Management Across Medical Device Product Development
What Were the Top Reasons FDA Issued Device Makers 483’s and Warning Letters in 2015
8 Reasons Design Controls and Risk Management Processes Fail
How Design Controls Apply to a 510(k)
Are Design Control Myths Holding Back Your Product Development?
MedTech Blunders in Risk Management
5 Tips to Help Your FDA 510(k) Submission (Checklist Included)
How to Prepare for an FDA Inspection
6 Development Steps to Fast-Track Your Medical Device's Path to Market
The Design Controls + Risk Management Connection: Using Design Reviews Effectively
An Alarming Device Trend: Why Getting 510(k) Clearance Alone is Not Enough
7 Steps to Respond to FDA 483 Inspection Observations
The Design Controls + Risk Management Connection €” Verification, Validation & Risk Controls
Design Controls & Risk Management: Two Sides of the Same Coin [Infographic]
Risk Management: A Total Product Life-Cycle Process [Infographic]
Risk Management for Medical Devices: An Introduction to The Process [Infographic]
Risk Management Definitions You Need to Understand
The Beginner's Guide to MedTech Design Verification and Validation
How to Avoid Exponentially Escalating Costs with Design Controls
The Design Controls + Risk Management Connection €” Intended Use & User Needs
5 Tips to Help You Prepare for an FDA Inspection
4 Reasons Your Risk Management Approach is Wrong
How to Make FDA Work for You €“ ATL Device Night
The $400,000 FDA Compliance Mistake You Don’t Want to Make
5 Tips for Better Medical Device Risk Management
How to Define Medical Device Design Inputs and Outputs
How Medical Device Complaints can Make You a Better Company
Case Study: 5 Mistakes that Lead to Flushing $400,000 in Fighting the FDA
How to Improve Your Medical Device Startup’s Funding Chances
Stop Treating Risk Management & Design Controls as Checkbox Activities
Three Ways to Determine Whether Your Medical Device Company Suffers From Disconnect
Is Your Risk Management System for Medical Devices Up to Date?
What's the Best Approach to Medical Device Design Reviews?
5 Tips to Help Your FDA 510(k) Submission (Checklist Included)
Top Three Document Management Tips for Medical Device Companies
3 Steps to Getting Your Medical Device Startup Off the Ground
Regulatory Classification 101: A Guide to How Your Medical Device Will Be Classified
What Issues Draw the Most Attention in FDA Medical Device Inspections?
The MedTech Adventures of Eddy the Engineer
15 Items Medical Device Startups Need to Address
Why Medical Device Startups Need to Master Juggling and Balancing with Focus
4 Medical Device Quality System Musts for Startups
The Art of Medical Device Design Inputs
Eight Questions that Define Your Medical Device User Needs
2 Things You Should Do Asap When Starting a Medical Device Project
Your 5 Step Blueprint for Great MedTech Design Reviews
How to Run Effective Medical Device Design Reviews
From Idea to Market Release: Your Quick Guide to FDA Design Controls
Case Studies
Monitored Therapeutics, Inc: Building an Audit-ready QMS in 3 Months
How Puzzle Medical Is Putting Together The Pieces For Success With Greenlight Guru
How A Partnership With Greenlight Guru Is Making This Dental Device Manufacturer Smile
How The Partner Ecosystem Has Been Key To Market Success For Spark Biomedical
First-in-Class Diagnostics Tool Gets 510(k) Clearance Thanks To Medical Device Success Platform
Medical Device QMS + Guru Medtech Experts: A Winning Combo For Global Market Success
Going From Weeks To Hours Of Audit Prep Time For Easy ISO 13485 Certification
6 Tips for a Seamless Document Migration to Greenlight Guru
How Solius Replaced Paper with eQMS to Gain ISO 13485:2016 Certification in Weeks
How Delta Development Fast-tracked R&D Down to a Single Year by Implementing a MDQMS
Photonicare Adopts Medical Device QMS Software to Accelerate Time to Market
Centese ditches paper-based QMS AND achieves FDA 510(k) clearance
How Innovere Accelerated Their Path To Market By Implementing Greenlight Guru’s Medical Device eQMS
Lucerno Dynamics Has Simplified the ISO 13485:2016 Certification Process With Greenlight Guru
How Amnion Life is Laying the Foundation for Success with Greenlight Guru
How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 5X in Two Years
How Priority Designs Used Greenlight Guru to Gain ISO 13485:2016 Certification
How SOLIUS Went from Scratch to an eQMS and ISO 13485:2016 Certification
Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]
The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]
LITG Case Study: Easily Documenting Design Controls to Accelerate Product Development
Sandstone Diagnostics Case Study: Moving from a Paper-based QMS to Greenlight Guru
Greenlight Guru Academy
Welcome to Greenlight Guru Academy
15 Steps to Creating a Risk-Based CAPA Process
3 Keys to Successful Internal Audits
3 Systems of Risk for Medical Devices
A Complete Guide to 21 CFR Part 11
A Complete Guide to Bringing a Medical Device to Market
Addressing the Notified Body Bottleneck
AMA: Join the discussion with the MedTech Excellence Community
An Overview of Design Controls
An Overview of Document Management
An Overview of Risk Management
A Step-By-Step Guide to Determine how your Medical Device will be Classified
A Step-By-Step Guide to Preparing your FDA 510(k) Submission
Behind the Stats: 2022 Medical Device Product Development & Quality Management Benchmark Survey
Biocompatibility Evaluation for Device Submission
Building a Regulatory Strategy Executive Summary
By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture
🚨 CAPA, Nonconformance, and Complaints limited time offering 🚨
CAPA Report Template for the Medical Device Industry
CE Mark Technical Documentation: Changes, Application, and Notified Body Expectations under MDR
Challenges with Applying Risk Management Throughout the Manufacturing Process
Change Management and Risk Management: How do we connect the dots and what happens if we don't?
Customer Feedback and Complaint Form Template
Design Controls, Development, and Risk for SaMD
Developing a New Clinically Relevant ICU Ventilator Fast
Documenting Risk Management to Meet Requirements of ISO 14971:2019
Economic Operators: Implementation Challenges and Opportunities
Effective Post-market Surveillance in the EU under MDR
Essentials for Clinical Evaluation of Medical Devices
Essentials of Software as a Medical Device
Evaluating need for Biocompatibility Testing & Mitigating Risks when Changing your Medical Device
From Concept to Commercialization
From Self-Declaration to Certification: Proving Performance Under IVDR
Greenlight Guru Lite User Training
GURU Workshop: Flexible Document Management
How and When to Conduct your First Hazard Analysis
How Risk Management Can Help Drive Innovation
How to Apply Risk Management Throughout the Product Lifecycle of your Medical Device
How to Create Medical Device Labels per EU MDR
How to Efficiently Document your Design Transfer to Ace your Audit and Product Launch
How to Embrace Risk for Safer Devices
How to Integrate Risk Management Throughout the Lifecycle of a Medical Device
How to Maintain a QMS Compliant to MDR & IVDR
How to Meet Cybersecurity Requirements of EU MDR & IVDR
How to Predict Medical Device Recalls using Publicly Available Data
How to Prepare for Common MDR Audit Pitfalls
How to Successfully Plan a Medical Device Product Development Project
Implementing and Maintaining Changes to SaMD Under MDR
Introduction to Design Control for Medical Devices
Introduction to Project Management for Product Development of Medical Devices
Introduction to Quality System Requirements in the USA and 21 CFR Part 820
Introduction to Risk Management for Medical Devices and ISO 14971
Introduction to Safety for Electrical Medical Devices and IEC 60601
Introduction to Software for Medical Devices and IEC 62304
Introduction to the Medical Device Regulation (EU) 2017/745
Introduction to Working in the Medical Device Industry
ISO 14971 Risk Management for Medical Devices
Key Milestones: How to Know When You're Ready for Your Next Round of Funding
Key Trends Shaping the Future of Medtech Innovation & Investment
Lessons Learned: MedTech Executives on the Fundraising Process
Managing Changes to Medical Device QMS
Managing Risks Along an IVD-Analyzer's Life-Cycle
MDR Date of Application Roundup: The New Landscape for Medical Device Manufacturers
MDR with Brexit: How the Combination is Impacting the European Medical Device Industry
Nonconformance Report Template
Panel: Funding and Go to Market Challenges for FemTech
Perfecting the Pitch: Fundraising Counsel from Seasoned Early Stage Investors
Planning your Cloud Connectivity Strategy to Reduce Cybersecurity and Privacy Risk
Pre-Market vs. Post Market Risk: What are the similarities and differences?
Prepare Now for the EUDAMED UDI/Registration Module
Protecting your Data from Risk: To, From, and In the Cloud
Quality Spotlight: Trials & Triumphs of Complaint Handling
Raising Capital for Medical Device Startups
Risk Management According to EU MDR or ISO 14971?
Risk Management for Executives: Why Does it Matter to Me?
Risk Management from a Regulatory and Product Development Perspective
Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World
SEEDing Biomedical Innovation: Support for Small Businesses at NIH
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
So You Think You Want to go to Europe? Considerations for Early Adopters of MDR
Standards and Pathways to the EU Medical Device Market
Standards and Pathways to the USA Medical Device Market
Strategies to Limit Project Timeline and Cost in Medical Devices
Supply Chain Management under the MDR, Brexit and Swixit
The Art of Defining Design Inputs and Design Outputs
The Beginners Guide to Design Verification and Design Validation for Medical Devices
The Definitive Guide to Change Management for Medical Devices
The Definitive Guide to Responding to FDA 483 and Warning Letters
The Importance of Design Controls
The Importance of Product Classification to Regulatory Strategy
The Ins and Outs of Supplier Management
The Intersection of Medical Device Usability and Risk Management
The Most Common Mistakes Health Tech Founders Make When Pitching
The New MDR: Is it Really New and Do We Really Need It?
The Path to Commercialization is No Easy Feat: Critical Milestones and Challenges
The Risk Management + Design Controls Connection: What Device Makers Need to Know
The Risk Management Process and ISO 14971
The Ultimate Guide to Design Controls for Medical Device Companies
The Ultimate Guide to Document Control for Medical Device Companies
The Ultimate Guide to ISO 13485:2016 Quality Management System for Medical Devices
The Ultimate Guide to Training Management for Medical Device Companies
The Who, What, and When of IVDR Enforcement
Tips for Working with Contract Manufacturing
Training Management in the Medical Device Industry
UDI and Device Registration, Another Launch Checkbox
Ultimate Guide to 21 CFR Part 820 - FDA's Quality System Regulation for Medical Devices
Ultimate guide to Agile Design and Development for Medical Devices
Understanding the Medical Device Single Audit Program (MDSAP): Pros, Cons, and How to Prepare
Using the Bucket Method for Medical Device Risk Management
What is the Best Way to Structure a Risk Management File
What Role Should Quality Play in Bringing a Device to Market?
What to do when FMEA is Not Sufficient Anymore
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Corrective Action vs Preventive Action
Corrective and Preventive Action Form
Corrective and Preventive Action Report
Quality Assurance vs Quality Control
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Randomization in Medical Device Clinical Trials: Everything You Need to Know
Design Controls Need to Start With User Needs
The Importance of Management Reviews for CAPAs
CAPA Best Practices: 4 Tips for Building an Excellent CAPA Process
How Technology Can Support Clinical Trial Continuity & Data Integrity
A Letter From the CEO: Celebrating 1,000 Medical Device Customers
Electronic Data Capture for Medical Devices: Then vs. Now
How to Use SMART-TRIAL by Greenlight Guru's ePRO Module
How ePRO Can Help Comply with EU MDR Post-Market Surveillance
Nonconformance (NC) and CAPA: When Should You Use Each Process?
Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)
What Device Makers Need To Know About Design Verification and Validation
Understanding Root Cause Analysis in the CAPA Process
How Does the EU GDPR Impact Medical Device Clinical Trials?
CAPA Process: Step-by-Step Instructions [+ Free Infographic]
8 Tips Before Calculating Sample Size in Medical Device Clinical Studies
Creating a Supplier Scorecard for Medical Device Supplier Management
Understanding FDA Cleared vs Approved vs Granted for Medical Devices
The Difference Between Managing Product & Services Suppliers in MedTech
MDCG Guidance Documents Overview on Clinical Investigations and Evaluations
7 Tips to Comply With FDA 21 CFR Part 11
Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR
GUDID 101: Everything You Need to Know About FDA’s Global Unique Device Identification Database
Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps
3 Common Misconceptions About Medical Device Labeling
10 Best Practices for eCRF in Medical Device Trials
How to Integrate UDI into a Quality System for Your Medical Device
Should ISO 15189 Certification Matter to Medical Device Companies?
Basic UDI-DI: What is it and How to Assign it for Your Medical Device
Guidance on How to Conduct Clinical Investigations Under EU MDR
Quality Assurance vs. Quality Control in the Medical Device Industry
MDCG 2020-5 Explained: How To Demonstrate Equivalency in the EU
Computer Software Assurance for Medical Devices: What Does FDA’s Draft Guidance Mean for You?
Generate MDR Compliant Clinical Data with Investigator-Initiated Studies
Ultimate List of ISO Standards for Medical Devices
21 CFR Part 11: A Complete Guide
FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours
Ultimate Guide to ISO 13485 for Medical Devices QMS
ISO 14971 Risk Management for Medical Devices: The Definitive Guide
Preparing for EUDAMED - Europe’s Medical Device Database
The Medical Device Practical Guide to PMCF Requirements under EU MDR
3 Tips For Incorporating Risk Management During Medical Device Product Development
9 Questions About the European MDR Answered
10 Tips for Selecting the Right EDC Software for Clinical Investigations
Medical Device Classification Guide - How To Determine Your Device Class
Ultimate Guide to Supplier Management for Medical Device Companies
IEC 82304 vs IEC 62304: Software Standards for SaMD Explained
Compliant Adverse Event Reporting in Clinical Studies under the EU MDR
What You Need to Know About Medical Device Software Validation
MEDDEV 2.7/1 Rev. 4 & MDCG Guidance: Carrying Out Clinical Evaluation Under EU MDR
eCRF Template for Clinical Investigations and PMCF Studies
AAMI TIR45: Closing the Gap Between Agile Software Development & Medical Device Regulations
MDCG 2020-6 Explained: Sufficient Clinical Evidence for Legacy Medical Devices in the EU
The Practical Guide to Post-Market Clinical Follow-up EU MDR Compliance
Explaining MDCG 2019-11: Software Qualification & Classification for MDR & IVDR
How to Design a Successful Post-Market Clinical Follow-Up (PMCF) Survey
The Essential Guide to Electronic Case Report Form (eCRF) for Medical Devices
Understanding FDA’s Special 510(k) Program
How to Communicate Your Regulatory Strategy to Medical Device Investors
How to Design an Electronic Case Report Form (eCRF) for Medical Device Studies?
Everything You Need to Know about Electronic Data Capture (EDC) Systems
eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use
How the Design Control Process Applies to a 510(k) Premarket Notification
How to Use Queries for Monitoring Medical Device Studies in SMART-TRIAL
Why Class 1 Medical Device Companies Need Design Controls (even if it’s not required)
What are the Risk Management Documentation Requirements of ISO 14971?
3 ISO Compliance Guidelines Every Medical Device Manufacturer Should Follow
Why is Post-Market Surveillance Important for Medical Devices?
Why Training Compliance Matters for Pre-Market MedTech Startups
3 Common Problems with Design Controls (and the Solutions)
Integrating Connected Device Data into Your Clinical Study
Downstream Effects of Inadequate Complaint Handling
What are the Distributor Requirements under EU MDR and IVDR?
3 Tips for Managing Your Medical Device Design History File
5 Signs Your MedTech Startup is Ready for the Next Round of Funding
Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each
Understanding The Relationship Between Usability and Labeling of Your Medical Device
How To Apply a Risk-Based Approach to Biological Evaluation
Selecting a Notified Body: How to Work with Your New Device Authority
4 Letter to File Mistakes That Could Cost You
Ultimate Guide to Software as a Medical Device (SaMD)
3 Stages of Project Management in the Medical Device Industry & How to Navigate Each
MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality
What Role Should Quality Play in Bringing a Medical Device to Market?
Who are the Economic Operators & What Does EU MDR Require of Them?
Applying for International Patents as a Medical Device Company
5 Strategies to Limit Project Timeline and Cost for your Medical Device
Setting up a Clinical Investigation under EU MDR
Greenlight Guru Academy Advance: The Future of MedTech Learning is Continuous
Quality Assurance vs. Quality Control in the Medical Device Industry
How to Build a Medical Device Business Case in 5 Easy Steps
Greenlight Guru Earns 2022 TrustRadius Top Rated Software Award
8 Questions That Define Your Medical Device User Needs
Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance
30/60/90 Day Plan To Making An Impact As A New QA/RA Manager
Post-Market Clinical Follow-up Under EU MDR: Your Guide To PMCF Activities
3 Tips For Planning A Successful Product Development Project For Your Medical Device
How To Make The Most Of True Quality 2022
Explaining UDI Requirements For GUDID And EUDAMED
Ultimate Guide To Clinical Evaluation Of A Medical Device In The EU
30/60/90 Day Plan To Making An Impact As A Product Development Engineer
3 Common Misconceptions About Medical Device Packaging
How To Create A Clinical Evaluation Report (CER) Under MEDDEV & MDR (part 4 Of 4)
Performing Data Analysis For Your Medical Device’s Clinical Evaluation (part 3 Of 4)
Everything You Need To Know About Root Cause Analysis
Greenlight Guru Consistently Ranked As A Trusted Partner For Leading Medical Device Companies
4 Problems (and Solutions) For The Medical Device Supply Chain
Understanding Technical Documentation In EU Regulations
Let The Document Tell The Story: Document Management Best Practices
Your Device Is Non-Significant Risk: Now What?
The Five Themes Of True Quality 2022
Software Bill Of Materials: What To Know About SBOMS For Medical Devices
What Is The Best Way To Structure A Risk Management File?
How To Convince Your Boss To Send You To True Quality 2022
Creating A Periodic Safety Update Report (PSUR) That Complies With MDR & IVDR
Design Vs. Utility Patents: Choosing The Right One For Your Device
Achieve Connected & Continuous Product Development: Introducing Greenlight Guru Products.
10 Reasons To Attend True Quality 2022
What You Need To Know About True Quality 2022
Bill Of Materials (BOM) For Medical Devices: Everything You Need To Know
Bringing Innovation And Quality To The Forefront | Greenlight Guru Acquires CanvasGT
3 Medical Device Security Challenges (And Solutions)
How Do FDA Medical Device Recalls Work?
Understanding The Quality Control Process In Medical Device Manufacturing
ISO 11137: An Introduction To Gamma Sterilization Validation
Best Practices For An Effective Medical Device Design Transfer Process
Top 40+ Medical Device Conferences To Attend In 2022 (Virtual + In Person)
Most Popular Medical Device Content In 2021
Cytotoxicity Testing: Ensuring The Biocompatibility Of Your Medical Device
Understanding Product Realization Under ISO 13485
IQ, OQ, PQ: A Quick Guide To Process Validation
UDI: Everything You Need To Know About Unique Device Identifiers For The FDA
What Does The IDE Application Process Involve?
Tips For Virtual Audits Your Medical Device Company Can Implement Today
Explaining The Role Of PRRC Under MDR & IVDR: Your Questions Answered
ISO 11607: A Primer On Packaging For Terminally Sterilized Medical Devices
Preparing For EUDAMED - Europe’s Medical Device Database
Transitioning To IVDR: The New EU Regulation For In Vitro Diagnostic Medical Devices
Engineering Change Order: The Role It Plays In The Change Management Process
Explaining IVDR Classification For In Vitro Medical Devices
ISO11135: An Overview Of Medical Device Sterilization Using Ethylene Oxide
How To Approach Corrective Action Requests With Medical Device Suppliers
The Growing Internet Of Medical Things (IoMT) & Its Implications For Medical Device Manufacturers
3 Non-Negotiables For Managing Business Risk As A Medical Device Company
What Are The SaMD Requirements From FDA?
Failure Mode Effects Analysis: What Is It & When Should You Use It?
What Is A Class 2 Medical Device In The US?
What’s The Difference Between Clinical Evaluation And Clinical Investigation?
IEC 62366 Explained: What You Need To Know About Usability Engineering
Medical Device 3D Printing: Should You Make The Move?
Clinical Testing For Medical Devices: What US Manufacturers Need To Know
Choosing An EU Authorised Representative (EC Rep) For Medical Device Regulatory Issues
Software As A Medical Device: Definitions, Examples & Regulatory Framework
European Authorized Representative For Medical Device Companies
3 FAQ About CE Marking Medical Device Manufacturers Want To Know
What Is A Class 1 Medical Device?
What Is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 Instead)?
Creating A Quality Manual That Complies With ISO 13485
How To Execute A Successful Product Launch
How Should Artificial Intelligence In Medical Devices Be Regulated?
3 Medical Device Reimbursement Strategies To Recoup Your Investment In The US
Debunking 4 Commonly Held Design Control Myths
What Is The FDA Medical Device Registration Process?
How To Assess The Impact Of Any Change To Your Medical Device (+ Free Checklist)
Top 3 Reasons For FDA 483 Observations In 2020
How To Use The MDSAP Companion Document
3 QMS Principles For Software As A Medical Device (SaMD) Manufacturers
Goodbye EN 1041. Hello ISO 20417:2021.
Driving MedTech Innovation With Safe And Effective Medical Devices
5 Biggest Quality Mistakes (And How You Can Avoid Making Them)
5 Postmarket Surveillance System Musts for Every EU Manufacturer
3 Things Med Device Startups Must Do When Implementing a QMS
7 Documentation Musts for All Software Device Premarket Submissions
3 Life[cycle] Hacks for Integrating Risk Management Throughout All Device Phases
Understanding the Premarket Approval (PMA) Process
How are Medical Devices Classified Under EU MDR?
How to Apply IEC 62304 Requirements for Medical Device Software
Understanding the FDA Medical Device Classification System
Cybersecurity for Medical Devices: Best Practices from Regulatory Standards
Choosing and Managing Your Medical Device Suppliers
Applying ISO 10993-1 to Medical Device Submission to FDA
Does My Device Labeling Comply with 21 CFR 801?
Understanding Intended Use from ISO TR 24971:2020
How the MDSAP Grading System Works
How MHRA is Regulating Medical Devices in the UK after Brexit
Top 30+ Medical Device Conferences to Attend in 2021 (Virtual + In Person)
Recruiting Top Medical Device Talent in a Competitive Market
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation
FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?
5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device
What is 21 CFR 812 - Investigational Device Exemption?
Top Risk Management Tools in the Medical Device Industry
5 Tips to Improve Your Medical Equipment Quality Assurance Activities
Answer these 3 Questions Before Developing Software as a Medical Device
How to Make Your QMS Comply with EU MDR and IVDR
4 Reasons to get ISO 27001 Certification
Three Tips for Designing at-home Monitoring Devices that Deliver Actionable Information
How to Build Medical Device Usability Testing and Validation into Your Quality System
Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps
5 Steps to Faster-to-market, More Profitable Medical Devices
How to Structure Your Medical Device Technical File
What is a Quality Agreement for Medical Devices?
Am I Complying with FDA Medical Device Labeling Requirements?
How to Use the FDA ESG (Electronic Submissions Gateway)
3 Valuable Outcomes of a Culture of Quality
What is a Traceability Matrix and How do I Create One for My Medical Device?
How to Demonstrate Substantial Equivalence in 5 Easy Steps
How to Use Voluntary Consensus Standards to your Strategic Advantage
5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes
How to Create a Quality Management Plan
Understanding ISO 13485 Training and Competency Requirements
5 Key Principles of Total Quality Management
How Does a Medical Device Quality Management System Differ from other QMS Tools?
Submitting a 510(k)? First Make Sure You Know What 'Substantial Equivalence' Means
Change Management Process Explained in 6 Easy Steps (+ free template)
How to Use the De Novo Pathway for your Medical Device
How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)
Understanding Change Management and Change Control in the Medical Device Industry
Most Popular Medical Device Content in 2020 from Greenlight Guru
6 Benefits of the Best 21 CFR Part 11 Compliant Software
What is the True Cost of Poor Quality for Your Medical Device Company? (Free Infographic)
12 Medical Device Experts Offer Best Tips for How to Succeed in 2021
Top 100 Medical Device Startups with Most Money Raised in 2020 (Free Chart)
Developing Pediatric Medical Devices: An Innovative Approach
Medical Device Biocompatibility 101
Everything You Need to Know about Human Factors Engineering for Your Medical Device
The Ultimate Internal Audit Checklist Every Medical Device Company Needs
Free Complaint Template for Medical Devices
Free Template: Nonconformance Process for your Medical Device
A Free CAPA Template for the Medical Device Industry
How to Write a Nonconformance Report
3 Reasons Why Closed-Loop Traceability is a QMS Must
CAPA Process - Step-by-Step Instructions [Infographic]
Quality Assurance vs. Quality Control in the Medical Device Industry
519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement
Unannounced Audits: A Survival Guide for Quality Managers
5 Tips for Medical Device Registration across Global Markets
How Do I Determine if my Product is a Medical Device?
What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?
Top 100 Medical Device Acronyms & Terminology You Need to Know
How to Escape the Lure of Legacy Quality Management Systems
Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records
How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations
How to Validate Cloud-based Software Tools
22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles
EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?
EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic
How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends
Documentation Priority for Early Stage Medtechs — Part 1: User Specification
How Software Architecture Enables Faster Release of New Clinical Tests to the Market
What are the Changes to ISO 14971:2019 & TR 24971?
COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health
10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead
4 Emerging Trends in 2020 Backed by Medical Device Industry Experts
Medical Device Companies - Top 100 in 2020 (Free Chart)
Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now
FDA Form 483 Observations and Warning Letters - What’s the Difference?
7 FDA Pathways to Bring Your Medical Device to Market
[VIDEO] How to Calculate the Cost Of Quality: Building the Business Case for your Medical Device QMS
[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)
[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)
Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)
4 Major Reasons to Use Document Version Control Software for your Medical Device
7 Tips to Comply With FDA 21 CFR Part 11
5 Steps for Getting your CE Marking with EU MDR Requirements
Top 10 Most Popular Greenlight Guru Posts of 2019
Top 40+ Medical Device Conferences To Attend in 2020
3 Pros and Cons to 3D Printing for Medical Devices
FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid
State of Medical Device Product Development and Quality Management Report 2020
Tips for Success with IEC 60601 for Electrical Medical Devices
How FDA Distinguishes Between Clearance vs. Approval vs. Granted
7 Tips to Attract Investors and Raise Funds for your Medical Device
4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)
Best Practices for Expediting Your Product Development
5 Tips from MedTech Executives on the Value of Quality
Why the FDA Pre-Submission is an Underutilized Tool
How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing
13 Tips For Audit Etiquette Every Medical Device Company Should Know
What is a Quality Culture? (and 7 tips for creating one)
6 Most Common Mistakes When Implementing ISO 13485
Everything You Need To Know To Perform Effective Root Cause Analysis
Should you Swipe Right or Left on your Notified Body?
Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)
FDA QSIT: Preparing Your Medical Device Company for an Inspection
5 Most Common Mistakes Made When Implementing ISO 14971
Qualifying Your Suppliers Using a Risk-based Approach
How to Write Effective SOPs for Medical Devices
8 Questions About the European MDR Answered
Top 50 Medical Device Product Design and Development Companies
De Novo Pathway: Explaining the Process for Medical Device Companies
ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums
Why Document Control Matters To Medical Device Companies
Abbreviated 510(k): Substantial Equivalence Through Performance Criteria
The Greenlight Guru True Quality Roadshow: Atlanta Recap
Quality, Fast, Cheap...Pick Two
What to Expect During an FDA QSIT Inspection
5 Most Common Problems with your CAPA Process
Introducing The Greenlight Guru True Quality Roadshow 2019
Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too
Why Contract Manufacturers Shouldn't Own Your Quality System
Top 10 Most Popular Greenlight Guru Posts of 2018
Defining Your Medical Device Design Records
6 Predictions for the Medical Device Industry in 2019 (and how you can prepare)
ISO 13485 & MDSAP Deadlines are Fast Approaching (And You Need a Notified Body)
FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing
3 Real World Document Management Horror Stories
Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!
Top 20 Medical Device Venture Capital Firms
5 Myths Engineers Believe About Quality (and what is really true)
How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)
Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)
FDA Aligning to ISO 13485:2016 (and Why It Matters)
What it Means to be Focused on Quality vs. Compliance
What are the Regulatory Expectations for Software as a Medical Device (SaMD)?
The Importance of Good Document Management (And How To Do It)
Why the FDA Case for Quality Matters
Scaling Regulatory and Quality with Your Company
FDA Case for Quality Program: What, Why and How?
AI Explainability: What That Means and Why it Matters in Healthcare
Challenging “Conventional Wisdom” in Medtech R and D
A Guide to Bridging User Needs Into Design Requirements
Why There is a Need for Multi-Level Design Controls
Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!
What Medical Device Developers Should Know About Human Factors
Tips for Running Effective Internal Quality Audits
Creating an Effective Quality Culture that Benefits Your Patients
Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)
Competitive Regulatory Strategy vs. Regular Regulatory Strategy
Timeline to ISO 13485:2016 (And Why You Need to Act Today)
7 Problems with a Paper-Based Design History File (And How to Avoid Them)
What You Need to Know About Risk Management and Using Post-Market Data
Understanding the New Requirements for QMS Software Validation in ISO 13485:2016
Quality Management Audit or Assessment?
Understanding the 5 Phases of Medical Device Development
4 Tips for Handling Nonconformances
How to Structure Your Internal Audit Program for the New Year (Plus 4 Tips)
Ultimate List of Medical Device Incubators and Accelerators (50+)
5 Predictions for the Medical Device Industry in 2018 (And How You Can Prepare)
Top 10 Most Popular Greenlight Guru Medical Devices Posts of 2017
15 Steps to Getting Approval for IEC 60601-1
How to Integrate Complaint Handling and Risk Management
How to Streamline the Customer Complaint Handling Process
13 Steps to Creating a Risk-Based CAPA Process
What is Software as a Medical Device (SaMD)?
Here Are the 4 Types of FDA Inspections You Need to Understand
How to Prepare for the Medical Device Single Audit Program (MDSAP)
How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers
Standard Conformity or Regulatory Compliance? Distinguishing the Two
What Does a Risk-Based QMS Mean?
What You Need to Know About the 510(k) Submission Process
FDA Inspections and ISO Audits: What is the Difference?
How to Switch to eQMS Software When You're Just Using Paper
Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities
The Do’s and Don’ts of an FDA Inspection
How to Translate Voice of Customer into User Needs
How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)
7 Common Mistakes That Can Delay Your FDA 510(k) Clearance
Debunking 8 Commonly Held CAPA Myths
How to Prepare Your Design History File (DHF) for an FDA Inspection
13 Common Pitfalls to Avoid During Medical Device Product Development
Design Validation vs. Clinical Evaluation: What’s the Difference?
5 Tips for Conducting Medical Device Management Reviews
How to Define and Decode Your Design Inputs and Design Outputs
Technical File vs. 510(k) vs. Design History File: What Medical Device Developers Should Know
How To Prepare for an FDA Inspection (Plus 5 Tips)
EU MDR and IVDR Are Live – Here Are Some Important Items You Should Know!
Clinical Evaluation Reports — Things You Should Know About the MEDDEV 2.7/1 Revision 4
Better Root Cause Analysis for Safer, More Effective Medical Devices
CAPA: When to Take Corrective Action or Preventive Action?
What is a “Quality Data Source” for your CAPA Process?
Tips for Conducting Better Root Cause Analysis for Medical Device Companies
This is a What … Unforeseen Pitfalls when Classifying a Medical Device
What Should Really Trigger a CAPA?
EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?
Fundamentals of Supplier Management for Medical Device Companies
Key Actions for Effective Customer Complaint Handling
5 Tips for Medical Device Engineers on FDA Design Controls
9 Keys to Enacting CAPA for Medical Devices Following Your Internal Audit
How to Speed up your Product Development Process
4 Key Compliance Issues for Medical Device Companies
What is CAPA in the Medical Device Industry?
Key Challenges for Risk Management in Medical Device Development
5 Things the Medical Device Industry Should Expect in 2017 (And How You Can Prepare)
A Review of the Most Important Medical Device Industry Topics in 2016
Top 10 Most Popular Medical Device Articles of 2016 (Plus Top 5 Free Webinars and Podcasts)
The Business Case for Integrated Design Controls
Medical Device Risk – ISO 14971 Gets It Right
An Introduction to FDA 21 CFR Part 11
FDA 21 CFR Part 820 vs. ISO 13485:2016 vs. ISO 13485:2003
What's with the Rush to First-In-Human Studies?
Why Poor Design Controls Mean More Medical Device Complaints
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time
Why Use ISO 14971 vs. FMEA (Template Included)
3 Common Misconceptions About Medical Device Packaging
5 Places Paper Might Be Hiding in Your Medical Device Company
3 Common Misconceptions About Medical Device Labeling
What It Means to Join the Greenlight Guru Family
8 Reasons Why Your Design Controls And Risk Management Processes Fail
What Medtech Startups Should Know About Quality Systems To Not Go Overboard
5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time
7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)
4 Medical Device Quality System Musts for Startups
4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer
Best Practices for an Effective Medical Device Design Transfer Process
Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015
Understanding Risk in Medical Device New Product Development (NPD)
Debunking 4 Commonly Held Design Control Myths
3 Tips for Managing Your Medical Device Design History File
Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?
8 Questions That Define Your Medical Device User Needs
Acronyms You Need To Know When Evaluating Medical Device Software Solutions
6 Medical Device Product Development Steps To Fast-Track Your Path To Market
Why Medical Device Startups Need to Master Juggling and Balancing With Focus
How Design Controls Apply to the 510(k) Process
Why FMEA is Not ISO 14971 Risk Management
Top 3 Document Management Tips for Medical Device Companies
4 Reasons Why Your Risk Management Approach is Wrong
Best Document Management Practices for Medical Device Startups: Don’t Cheap Out
20 Most Popular Medical Device Posts of 2015 from Greenlight Guru
Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)
5 Reasons Why You Need To Implement a QMS or Bust
Paper Systems Are the Riskiest Way to Manage Medical Device Projects
The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong
Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?
How To Flush $400,000 Down the Drain Fighting the FDA
3 Tips for Incorporating Risk Management Throughout Medical Device Product Development
Understanding ISO 14971 Medical Device Risk Management
Design Reviews – Are More or Less Better?
A Brief Introduction to Medical Device Risk Management (Plus 5 Tips)
How To Avoid a Medtech Documents & Records Scavenger Hunt
Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters
5 Tips to Help Your FDA 510(k) Submission (checklist included)
2 Things You Need To Do ASAP When Starting A Medical Device Project
How To Reduce & Prevent Medical Device Complaints
Medical Device Product Development Case Study
Changing Medical Device Design Control
You do know Design Controls are required for medical devices, right?
