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Podcasts

Global Medical Device Podcast

Why Usability Matters

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

Meet a Guru: Maryann Mitchell

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

Meet a Guru: Ryan Behringer

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

Meet a Guru: Etienne Nichols

Meet a Guru: Laura Court

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?

Meet a Guru: Sara Adams

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

Building a Startup in the MedTech Industry

Meet a Guru: Karen Schuyler

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

Meet a Guru: Erica Loring

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

Meet a Guru: Wade Schroeder

What are the Audit Etiquette Rules I Should be Following?

Meet a Guru: Tom Rish

Addressing Clinical Trial Challenges & Concerns during COVID-19

Protecting the Intellectual Property of your Medical Device Technology

Meet a Guru: Jesseca Lyons

How to Build a QMS for a Medical Device

Meet a Guru: Taylor Brown

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?

Preparing for EU MDR

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

Right-sizing your QMS

Challenges with Pediatric Medical Devices

When Should You Start a QMS?

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

Who Should Own Your QMS?

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

What's New With PMAs

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

How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy (And How to Use It to Your Advantage)

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

How SimplicityMD Is Leveraging Technology Plus a Lean Approach to Help Get Their Devices to Market Faster

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

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

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

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

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

The Difference Between Intended Use and Indications of Use (And Why These Statements Are So Important)

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

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

An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson, a Member of the Standard's Working Group

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 Identify, Quantify and Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

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

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

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

Greenlight Guru Launches Guru Assist, On-Demand Lifeline To Medical Device Experts

Greenlight Guru And Formlabs Partner To Mitigate Risk And Accelerate Product Development In Order To Improve Patient Outcomes

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

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2021

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 Launches Greenlight Guru Academy as a Trusted Source of Education to the Global Medical Device Community

Greenlight Guru Announces True Quality Summit Series: EU MDR & IVDR

Greenlight Guru Launches Halo℠ For Change Management, World’s First AI & ML Recommendation Engine for Medical Device Quality

Greenlight Guru and Nelson Labs Announce Strategic Alliance to Mitigate Risk and Guide Customers to Market Faster

Greenlight Guru Introduces Training Management to Simplify Regulatory Compliance and Streamline the Employee Training Process

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 Launches Visualize to Redefine the Medical Device Industry’s Approach to Closed-Loop Traceability

Greenlight Guru and EMERGO by UL Announce Strategic Alliance

Greenlight Guru Updates Risk Management Capabilities to Align with ISO 14971:2019, Further Enhances Change Management Capabilities

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

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

Medical Device Project Plan

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

Change Order 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

Training Matrix Template

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

Biocompatibility Testing Selection Criteria

Human Factors & Usability Engineering Report

Complaint Template

Nonconformance Template

CAPA Template

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

IVDR Gap Assessment Tool

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

Quality Culture Flowchart

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

EU MDR Gap Analysis 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

FDA Program Comparison Table

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

510(k) Submission 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

6 Survey Tools for Gathering User Needs

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

Risk Management Plan Template

5 Tips to Help Your FDA 510(k) Submission

 
eBooks & Guides

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)

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

EU MDR Implementation 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

Change Management

Quality Management System

Webinars

Notified Body + Manufacturer Face-Off: Inside Scoop From Both Sides On How To Address MDR Misalignment

Breakthrough Device Designation & Its Impact On Reimbursement

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

The Power Of 3D-Printed Medical Devices: Proven Regulatory Strategies & Quality Recommendations To Use For Additive Manufacturing

Tips & Tricks For Customizing A Clinical Trials Program For Your Medical Device, IVD, Or Digital Therapeutic That Satisfies Regulators, Investors & Patients

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

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

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

Attention ⚠️ ISO 15223-1 4th Edition is almost here: How to update your medical device labeling to comply with the new requirements

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

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

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

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

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

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

3 Ways Medical Device Companies Working Remote are Leveraging QMS Software to Foster Innovation and Collaboration

How Can Medical Device Companies Use the Emergency Use Authorization (EUA) to Address the COVID-19 Pandemic?

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

Post-Market Surveillance for Medical Devices and Combination Products: If a Device is FDA Cleared or Approved, Can We Assume it’s Safe and Effective?

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

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

How to Avoid Common Problems With Your Design, Risk, and Validation Documentation

Prepping Your QMS for EU MDR

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

2021 State of Medical Device Report

2021 EU MDR Research Report

 

Events

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

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

JMI Equity invests more than $120M in startup to help medical device companies navigate regulatory hurdles

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

Best Workplaces 2021

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

Hello Halo

Virtual Summit to Help Understanding of New EU Regulations

Greenlight Guru Announces True Quality Summit Series

Greenlight Guru is Boosting its MedTech Quality Management Software with AI

Greenlight Guru Launches Halo for Change Management, World’s First AI & Ml Recommendation Engine for Medical Device Quality

New AI Recommendation Engine Launched for Medical Device Quality

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 and Emergo by Ul Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

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 EVP

Big Wigs and New Gigs

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

Greenlight Guru, an Indianapolis Firm that Produces Quality-Management Software for Medical Device Companies, Announced a Webinar Series with the U.S. Food & Drug Administration

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 Adds to Team

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 Announces Partnership with Yeng & Leong Medtech Consultancy to Distribute eQMS Software Solution in Asian Markets

Quality Management Platform enabling Medical Device Companies to get Products to Market Safer and Faster with Less Risk

eQMS Software Provider greenlight.guru Inks Partnership with MedTech Regulatory Compliance Consulting Firm Pearl Pathways

greenlight.guru Pitches New Medical Device Risk Management Software

greenlight.guru Changes the eQMS Landscape with Release of New Risk Management Software for Medical Devices

Centric Names Innovation Award Winners

Health Tech Startup greenlight.guru Secures $1.25MM, Launches QMS Software

Software: Head in the Cloud - The Movement Toward Cloud-Based Information Storage in Medical Manufacturing is Slow Due to Regulatory and Privacy Concerns, but Steady.

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

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

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

Preparing for the EU’s MDR

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

Paper is Expensive

The True Cost of Paper

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

Creating an It Factor Culture

2019 MedTech Predictions

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

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

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

What a Risk-Based QMS Means

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

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

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

Navigating the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

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)

Why FMEA is Not ISO 14971

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)

Risk: Look at the Big Picture

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

How MedTech Startups Can Navigate Design Controls

Case Studies

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

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

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

C2DX, Inc. Impresses auditors and Breezes through MDSAP AUDIT After Implementing Medical Device QMS (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

GURU Certification Level 1

GURU Certification Level 2

GURU Certification Level 3

15 Steps to Creating a Risk-Based CAPA Process

3 Keys to Successful Internal Audits

3 Systems of Risk for Medical Devices

Addressing the Notified Body Bottleneck

Administration and User Management

An Overview of Design Controls

An Overview of Document Management

An Overview of Risk Management

Applying a Risk-Based Approach to Biological Evaluation of Medical Devices Based on the Framework of ISO 10993-1:2018

Audit Basics

By Design: Reduce Risk and Improve Compliance with a Layered Software Architecture

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?

Design Controls, Development, and Risk for SaMD

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

Europe's First Device Regulations: A Look Into Manufacturers' Response to the Delay, Transition, & Implementation Process

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

FDA 510(k) Overview

From Self-Declaration to Certification: Proving Performance Under IVDR

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 Embrace Risk for Safer Devices

How to Implement Risk Management into Regulatory Submissions Using Tips, Tricks, and Standards to Satisfy FDA Concerns

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

Implementation of the Risk Management Board for New Product Introduction and Post Market Surveillance

Implementing and Maintaining Changes to SaMD Under MDR

Introduction to Design Control for Medical Devices

Introduction to Risk Management for Medical Devices and ISO 14971

ISO 14971 Risk Management for Medical Devices

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

Prepare Now for the EUDAMED UDI/Registration Module

Protecting your Data from Risk: To, From, and In the Cloud

Remote audits

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

Risk Management Plan Template

Risks that No One Wants to Talk About: Theoretical Risk Management vs. Life in the Real World

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

Standards and Pathways to the USA Medical Device Market

Supply Chain Management under the MDR, Brexit and Swixit

The Intersection of Medical Device Usability and Risk Management

The New MDR: Is it Really New and Do We Really Need It?

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

The Road to 2024: Regulatory Risks Related to Changed Post-Market Surveillance Requirements and Notified Body Certification

The Who, What, and When of IVDR Enforcement

Training Management in the Medical Device Industry

Understanding Device Classification and Other Significant Changes Under IVDR

Using the Bucket Method for Medical Device Risk Management

What is a Medical Device?

What is the Best Way to Structure a Risk Management File

What to do when FMEA is Not Sufficient Anymore

Who Owns Risk Management and How Does it Impact the Business?

 

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Glossary

IEC 60601

IEC 62304

Bill of Materials

Root Cause Analysis

Predicate Device

FDA Warning Letters

Standard Operating Procedure for Medical Devices

EU IVDR

Technical File vs Design Dosier

Notified Body

Human Factors and Usability

Wearable Medical Devices

Customer Complaint Handling Process

QMS Manual

FDA 510k Clearance

FDA Form 483

Quality Assurance Testing

Quality Assurance Auditing

ISO 13485 VS 9001

Quality Assurance Process

GMP Compliance

New Product Introduction Process (NPI)

Quality Control System

Unique Device Identification (UDI)

Document Control System

21 CFR 803 Medical Device Reporting

FDA 510(k) Database

MedWatch Form

Medical Device Regulations

ISO Medical Device Standards

MDSAP

Electronic Medical Device Reporting

MEDDEV Vigilance

EQMS

Quality Management Process

Medical Device Clinical Trials

Medical Device Life Cycle

Labeling Medical Devices

Medical Device Reporting

Document Control Standards

Document Control SOP

Document Control Plan

FDA CGMP

Electronic Batch Records

ISO 13485 Audit

Corrective Action Plan

Risk Matrix

Corrective Action vs Preventive Action

Corrective and Preventive Action Form

Corrective and Preventive Action Report

Nonconformance Management

Corrective Action Procedure

Postmarket Surveillance

Medical Device Design

ISO 13485 Requirements

FDA Audit

Document Control

EU MDR

MedDev 2.7/1

FDA QSR

510K vs PMA

FDA 483

Quality Assurance vs Quality Control

ISO 13485 Standards

ISO 13485 Certification

Design Controls

Medical Device Classes

Medical Device Design Verification

What is DHF (Design History File)?

What is Device Master Record (DMR)?

What is Device History Record (DHR)?

ISO 9001

Quality Management Tools

CE Marking

ISO 14971

Corrective and Preventive Action (CAPA)

ISO 13485

510k Submission

21 CFR 820

21 CFR Part 11

QMS (Quality Management System)

Quality Assurance (QA) Systems

 

Solutions

QMS Software Overview

Intelligent Document Management

Greenlight Guru Visualize

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Blog

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?

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions In The Medical Device Industry

Failure Mode Effects Analysis: What Is It & When Should You Use It?

What Is A Class 2 Medical Device In The US?

7 Project Management Tips

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)?

What Is An ISO Audit?

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

Special 510(k) vs. Abbreviated 510(k) vs. Traditional 510(k): Which FDA Program Applies to My Device?

Why a Visual QMS is So Important for Your Medical Device Company

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)

Say Hello to Predictive Quality: Greenlight Guru Introduces Intelligent Document Management powered by Halo℠

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)

Streamline the right training, for the right people, at the right time. Introducing Greenlight Guru Training Management

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

Introducing Greenlight Guru Visualize: Quality at a Bird’s Eye View

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] 7 Ways to Track QMS Effectiveness using Medical Device Post-market Quality Processes (Track Phase)

[VIDEO] How to Prepare your QMS for a Successful Medical Device Product Launch (Release Phase)

[VIDEO] 4 Medical Device Manufacturing Best Practices for a Successful Design Transfer (Approve Phase)

[VIDEO] Integrating Design Controls & Risk Management To Streamline Product Development (Make Phase)

[VIDEO] 3 Easy Steps to Establishing a Quality & Regulatory Strategy for your Medical Device (Scope Phase)

[VIDEO] How to build a medical device QMS using the best people, processes & technology (S.M.A.R.T Methodology)

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

How To Navigate the Difficult Road of Medical Device Product Development While Avoiding the Common Pitfalls

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?

An FDA Inspection Will Happen

Design Controls Need to Start With User Needs

Design Controls are the #1 Most Cited Issue with FDA