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Why Your Company Needs a QMS Software or eQMS

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

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

Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

Real-World Data and Real-World Evidence: When and How to Use Them

What Standards Apply to My Device?

Ultimate Guide to In Vitro Diagnostic (IVD) Devices

A Free CAPA Template for the Medical Device Industry

Design of Experiments - How and When to Use DOE

7 Steps to Respond to FDA 483 Inspection Observations (Response Template Included)

Cybersecurity for Medical Devices: Best Practices from Regulatory Standards

MedTech Advice from an Accidental Entrepreneur

Strategies for Successful PMA Submissions: A Guide for Clinical Teams

Navigating the Complex World of Combination Products

Top 100 Medical Device Acronyms & Terminology You Need to Know

QMSR Explained: What FDA QSR & ISO 13485 Harmonization Means for Medical Device Companies

Meet the Guru: Building Quality Management in Early-Stage Medical Device Companies

Who Owns the Design Controls Process?

How to Set Up Clinical Studies to Comply with US FDA Regulations

5 Elements that Must Connect to Your Design Controls for an Audit-Proof QMS

Designing a Medical Device for a Global User

FDA's Proposed Wound Dressing Rule: Industry Impacts & Regulatory Insights

Post-Market Surveillance for Medical Devices & IVDs: Requirements & Proactive Data Collection

Data Management and Reporting in FDA-Regulated Clinical Trials

Biocompatibility Testing for Medical Devices 101

Direct to Consumer - The Future of Healthcare

How 4 Pre-Market MedTech Companies are Leveraging Greenlight Guru Quality

A Guide to Bridging User Needs Into Design Requirements

ISO 13485 and FDA QSR: A Step-by-Step Guide to Complying with Medical Device QMS Requirements

MDR and IVDR: Challenges and Opportunities of the New Regulations

Clinical Evidence: The Key to Market Adoption

Paper Systems Are the Riskiest Way to Manage Medical Device Projects

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

LDT Enforcement Discretion Phaseout: What You Need to Do in the First Year

2024 Greenlight Guru True Quality Roadshow: Copenhagen Recap

Creative Clinical Recruitment

Why FMEA is Not ISO 14971 Risk Management

How to Define Your Design Inputs and Design Outputs

How to Carry Out PMCF Activities According to EU MDR

Getting Hired In MedTech

FDA Issues LDT Final Rule to Regulate Laboratory Developed Tests as IVD Devices

Achieving ISO 13485 Certification

QMSR & the End of DMR, DHR, DHF: How FDA’s New Rule Impacts Record-Keeping

Meet a Guru: Jamie Bihary

Advice to Medical Device Inventors

FDA’s PMA Supplements and Amendments: When and How to Use Each

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

IQ, OQ, PQ: A Quick Guide to Process Validation (Plus Free Resources)

Obtaining Institutional Review Board (IRB) Approval

MDCG 2024-5: Guidance on the Investigator’s Brochure Explained

Interviewing the Interviewer

Beginner's Guide to Design Verification & Design Validation for Medical Devices

Ultimate Guide to Device Class Requirements under EU MDR

Cardiac Arrest: 5 Heart-Stopping Years as a CEO on the Feds Hit-List

Entering the Australia & New Zealand Markets: What Medical Device Manufacturers Need to Know

QMS Principles for Software As a Medical Device (SaMD) Manufacturers

Medical Device Reporting: The Do's and Don'ts

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

How are Medical Devices Classified under EU MDR?

MDCG 2024-3: What the Latest Guidance on Clinical Investigation Plans (CIP) Tells Us

Building a Partnership with your Regulatory Consultant

Bringing a Self-Funded Medical Device to Market

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

Managing Risk in Clinical Investigations

Definitive Guide to Change Management for Medical Devices

Speaking the Language of IVD

Top 50 Medical Device Product Design and Development Companies

Is It Possible to "Buy" a QMS?

Ultimate Guide to Clinical Data Management in MedTech

FDA 510(k) Submission: A Step-By-Step Guide On How To Prepare Yours

What is a Class III Medical Device in the US?

Improving Study Management in MedTech with Greenlight Guru Clinical’s Custom Collaborator Roles

Greenlight Guru Shines in G2 Spring 2024 Report, Dominating in Medical QMS and EDC Categories

Project Management in MedTech

Meeting Timelines and Managing Budgets - Best Practices for MedTech Clinical Investigations

Medical Device Classifications - How To Determine Your Device Class

Ultimate Guide to ISO 13485 for Medical Devices QMS

Step-by-Step Guide to FDA PMA Submissions for Class III Medical Devices

How to Take Control of Training Management and Stay Compliant with ISO 13485:2016 and Part 820.25

Ready to Submit Your FDA 510(k)? But Wait, There's No Human Factors!

FDA's Voluntary Improvement Program

The Ultimate Guide To Design Controls For Medical Device Companies

Quality Management Plan - How to Create Yours (Tips & Best Practices)

The State of UDI Across the World

How to Structure your Medical Device Technical File

Adopting AI in Quality Management: Practical Solutions for the MedTech Industry

Outsourcing Clinical Activities in 2024: Choosing A CRO

Quality Assurance vs. Quality Control in the Medical Device Industry

ALM and Design Controls: Do SaMD and SiMD Manufacturers Need Both?

How MHRA is Regulating Medical Devices in the UK after Brexit

Investigator Initiated Studies — 3 Common Problems and How to Fix Them

Quality Myths & Lessons Learned Part II

5 Habits of Highly Effective MedTech Companies

Mastering the Pitch: MedTech Innovations from Concept to Market

How to Use the Turtle Diagram for Better Internal Audits

Greenlight Guru Announces the 2024 True Quality Roadshow

Clinical Data Collection - 7 Key Pitfalls To Avoid In MedTech

Becoming a MedTech Regulatory Affairs Professional

Top Medical Device Conferences To Attend in 2024

FDA Publishes Final Rule on QMSR

Introducing Risk Reviews for Efficient, Compliant Risk Management

Calculating Nonconformance Costs in the MedTech Industry

Selecting a Notified Body: How to Work with Your New Device Authority

How Artificial Intelligence is Impacting the MedTech Industry

Greenlight Guru Finishes 2023 with Strong Momentum in Q4

Fundamentals of Quality & Regulatory

IVDR: How to Meet the Quality Management System Requirements of a Device

Navigating Clinical Evaluations and Investigations in MedTech

The State of AI & Clinical Investigations

How PLM and QMS Solutions Work Together in MedTech

The Evolving Landscape of AI in MedTech

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Climbing the MedTech Career Ladder - How to Get to the Top

Greenlight Guru’s MedTech Suite Named a Leader in G2 Winter 2024 Grid Report

Customers Rank Greenlight Guru Quality as Medical QMS Leader in G2 Winter 2024 Report

Greenlight Guru Clinical: Leader in the EDC Category in G2 Winter 2024 Grid Report

Most Popular Medical Device Content in 2023

Considerations for IVD

Moving MedTech Forward: Greenlight Guru’s 2023 in Review

Top 40+ Medical Device Contract Research Organizations (CROs)

Human-Centered Design in Medical Devices

Electronic Data Capture (EDC) Buyer’s Guide: Making the Business Case for a New EDC System

FDA's eSTAR Program

AI, Automation, and Risk in MedTech

A Better Way to Develop a Medical Device with Digital and Physical Elements (Part 1 of 2)

A Better Way to Develop A Medical Device with Digital and Physical Elements (Part 2 of 2)

Using AI in MedTech

The Ugly Truth About Managing Design Controls on Spreadsheets

Becoming an Advisor to a Medical Device Company

Enterprise Quality Management Software: What You Need To Know

Recent FDA Draft Guidances

Ultimate Guide to Supplier Management for Medical Device Companies

Greenlight Guru Releases The AI in MedTech Trend Report 2023

The AI in MedTech Trend Report 2023 Is Here

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

Planning an FDA Submission

Benefits of Switching from MasterControl to Greenlight Guru

Reducing Medical Device Risk with Usability Testing: The Why, the How, and the Who

Ultimate Guide to Software as a Medical Device (SaMD)

Top 7 QMS Tools for MedTech (Plus 4 Bonus Resources)

What NOT to say to FDA

Ultimate Internal Audit Checklist: FDA QSR & ISO 13485 Audit Checklist

Greenlight Guru Expands Market Leadership with Strong Momentum in Q3 2023

IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

5 Foundational Steps of a CAPA Quality Process

Understanding LDTs & the FDA Proposed Ruling

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

EU MDR - 9 Top Questions Answered (European MDR)

FDA Proposes New Rule to Regulate LDTs as IVDs: Here’s What’s at Stake

23 Must-haves for your Product Requirements Document (Free Checklist + Guide)

UDI and EUDAMED: Past, Present and Future State

MHRA Guidance Document on Clinical Investigations in UK

Guide to Understanding AI Applications that Drive Business Value in MedTech

Selecting a Site for Your Clinical Trial

Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

Greenlight Guru Celebrates 10 Years by Introducing its Multi-Product MedTech Suite

Introducing The Greenlight Guru MedTech Suite: A Comprehensive Set Of Industry-Specific Solutions

Ultimate Guide to ISO 14155:2020 for Medical Devices

How To Approach Supplier Corrective Action Requests (SCAR)

5 Tips for Medical Device Registration across Global Markets

Engineering Change Order: Its Role in the Change Management Process

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

Greenlight Guru Yet Again Ranked as a Leader in QMS and Medical QMS Categories in G2 Fall 2023 Grid Reports

How to Structure a Clinical Investigation Report (CIR) Summary

Accelerating SaMD Development in a Compliant Agile Way

Creating a Supplier Scorecard for Medical Device Supplier Management

What is a Predetermined Change Control Plan (PCCP) and Who Needs One?

MedTech Funding and Preparing for Due Diligence

3 Tips for Adding Flexibility to Your MedTech Manufacturing Supply Chain

Exploring Breakthrough Device Designation

What is the FDA Medical Device Registration Process?

Machine Learning, AI and Risk Management: TIR34971 Explained

Regulatory Strategy and the Advantage of Diversity in MedTech

How to Comply with HIPAA and EU GDPR in Medical Device Studies

Greenlight Guru Invests in State-of-the-Art Arena and Training Facility That Aims to Help Youth Basketball Players On and Off the Court

Conducting Quality Investigations in Medical Device Manufacturing

28 Days To Save The World - True Quality Roadshow

Omnibus Act Impact on Medical Device Cybersecurity

Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

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

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

FDA Guidance on Artificial Intelligence (AI) in Medical Devices

Greenlight Guru Continues Strong Growth in Q2 2023 Powered by Product Innovation

How to Improve Detecting, Correcting, and Preventing Nonconformances

Ultimate List of ISO Standards for Medical Devices

The Role of dFMEA in Risk Management for Medical Devices

Understanding the ROI of an eQMS

CSA vs. CSV: Modern Validation for Modern MedTech

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

Identifying and Evaluating Medical Device Importers

Writing a Clinical Investigation Plan (CIP): The Essential Guide

Management Responsibility: The most important part of a QMS

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

How to Develop a Risk-Based Approach to Supplier Management

Customers Rank Greenlight Guru Leader in QMS and Medical QMS Software in G2 Grid Reports for Summer 2023

Alternatives to PMCF Clinical Investigations

The Combination Products Handbook

15 Reasons Why Medical Device Companies Choose Greenlight Guru

How to Manage Complex Downstream Design Changes to Your Medical Device

Purpose-Built QMS vs General-Purpose QMS: What You Can Expect From Each

Leaning into Lean Documentation

Greenlight Guru Publishes Independent Study Showing the ROI of eQMS Solutions on MedTech Companies

How to Plan and Budget for MedTech Clinical Activities

CSV vs. CSA: Exploring FDA’s New Software Validation Approach

Making the Business Case for an eQMS Solution for Your Company

Cybersecurity and the Future of MedTech

Greenlight Guru Modernizes Validation Approach to Streamline Software Implementation and Adoption for Medical Device Companies

Managing Major Changes to Medical Device Packaging

5 Tips for Designing a Medical Device Study Under FDA Requirements

What is a Modern QMS?

4 Tips for Managing Your MedTech Portfolio

Ad Promo and The Difference in Regulatory & Legal

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

2023 Greenlight Guru True Quality Roadshow: San Jose Recap

How AI Can Help You Manage Risk

How To Vet Medical Device Distributors in Multiple Markets

What is the Best Way to Structure a Risk Management File?

7 Tips for FDA 21 CFR Part 11 Compliance

The Tools that Make Clinical Investigations

Understanding ISO 14971 Medical Device Risk Management

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

5 Dos and Don'ts when Choosing a QMS Solution for Your Medical Device Company

Introducing Risk Solutions: A New Era in Risk Management for MedTech

Greenlight Guru Launches AI-Powered Solutions to Enable Better Risk Management for the MedTech Industry

How to use the Greenlight Guru Clinical AE/SAE reporting module

Planning Your Medical Device Global Market Regulatory Strategy

Complaint Handling with Medical Device Guru, Brittney McIver

Why Clinical Data Is Essential to Value-Based Healthcare

3 Things to Love about Internal Audits

HTEC Group Partners with Greenlight Guru to Accelerate Time-to-Market for Medical Device Companies

Avoiding Potential Issues with your 510(k) Submission

4 Advantages of an eQMS Over a Paper-Based QMS

Meet a Guru: Brittani Smith

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

Greenlight Guru Builds Strong Momentum in Q1 2023 as Medical Device Companies Move to Modern Digital Solutions

4 Reasons to Stop Mixing Your Clinical Data Collection Methods

How To Avoid a Failed QMS Implementation

5 Steps for Getting your CE Marking with EU MDR Requirements

2023 Greenlight Guru True Quality Roadshow: Houston Recap

Why Building Supplier Relationships Is So Important

Post-Market Clinical Follow-up Under EU MDR: Guide to PMCF Activities

Can dFMEA and ISO 14971 Co-Exist in Medical Device Risk Management?

“A Perfect eQMS”: Customers Rank Greenlight Guru #1 QMS in G2 Spring 2023 QMS Grid Report

ePRO vs Paper: The Debate Over Patient Reported Outcomes Is Over

Systematic Literature Review for EU MDR

From Closed to Connected: Share Data & Unlock Efficiencies with Greenlight Guru’s Export API

Greenlight Guru Introduces Export API for a Connected Quality Management System

5 Tips for Running Effective Internal Quality Audits

eBOM vs mBOM: What’s the Difference?

Medical Device Adverse Event Reporting Regulations: EU vs. US

Building Your Design Controls (and Pitfalls to Avoid)

Electronic Data Capture Systems vs. Paper-based Data Collection

How to Handle Medical Device Adverse Events

Explaining IVDR Classification for In Vitro Medical Devices

Most Common Problems Found During FDA Inspections in 2022

Complete Guide to Bringing a Medical Device to Market

Making the BOM & Design Controls Connection

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

Clinical Data Management System (CDMS) for Medical Device Clinical Trials

Everything You Need to Know About Electronic Data Capture (EDC) for Clinical Trials

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

Top 30 MDCG Guidance Documents for Medical Device Companies

Top 40 IMDRF Technical Documents for Medical Devices

Good Clinical Practice (GCP) Compliance in Clinical Data Collection

Understanding the 'Compliance Manager' Role

21 CFR Part 11: A Complete Guide

Research shows eCRFs faster, more reliable than paper CRFs

How to Define User Needs During Design Controls

Greenlight Guru Introduces Newly Expanded Global Partner Program

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

Does My Device Labeling Comply with 21 CFR 801?

Utility Patent vs Design Patent: Choosing the Right One for Your Device

How to Switch from Paper to EDC Systems in Your Next Clinical Study

Ultimate Guide to Postmarket Surveillance of Medical Devices

7 Essential Steps of a Nonconformance Report

How to Choose an Electronic Data Capture System to Comply with EU MDR

Switching to an Electronic Device History Record (eDHR): What Medical Device Companies Should Know

What is a Class 1 Medical Device?

How Communication Affects the Outcomes of Quality Activities

FDA Human Factors Guidance Draft: What Medical Device Manufacturers Need to Know

3 Factors that Impact Application of Decentralized Clinical Investigations for Medical Devices

Top 100 Medical Device Companies (Free Chart Included)

Part 2: The Theranos Loophole & Lab Developed Tests

How Electronic Data Capture is Transforming the MedTech Industry

5 Processes You Need to Invest In to Bring a Device to Market

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

What is a Document Control System?

Part 1: The Theranos Loophole & Lab Developed Tests

The Pitfalls of Using Paper and Excel for Clinical Data

How to use eConsent Efficiently in Medical Device Studies

Tips for Ensuring Your Clinical Data Complies with FDA's 21 CFR Part 11

Applying ISO 10993-1 to Medical Device Submission to FDA

What is a Class 2 Medical Device in the US?

Top Risk Management Tools in the Medical Device Industry

Process Verification vs Process Validation: What’s the Difference?

Best Practices for eConsent in Medical Device Clinical Investigations

FDA Form 483 Observations and FDA Warning Letters - What’s the Difference?

What is 21 CFR 812 - Investigational Device Exemption?

Creating a Periodic Safety Update Report (PSUR) that Complies with MDR & IVDR

Implementing an eQMS after Switching from Paper

Greenlight Guru Announces 2023 True Quality Roadshow

Greenlight Guru Releases 2023 MedTech Industry Benchmark Report

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

How to Collect PMCF Data for Lower-Class Medical Devices and WETs

Essentials of Sterilization for Med Device Professionals

The Essential Guide to eCRF (Electronic Case Report Form) for Medical Devices

The Medical Device Development Process: A Deep Dive into the 5 Phases

UDI: 101

How to Plan a Clinical Data Management Setup for EDC Systems

Quality Myths and Lessons Learned

Greenlight Guru Announces Partnership with Comply Guru

Understanding FDA Cleared vs Approved vs Granted for Medical Devices

Explaining the Role of PRRC under MDR & IVDR: Your Questions Answered

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)

9 Steps to Creating a CAPA Audit Checklist

Determining User Needs for Your Medical Device

The 3 C’s of the EU MDR: Changes, Challenges and Contributions

Fraud in the Healthcare Industry & the Role of Whistleblowers

GUDID 101: Everything You Need to Know About FDA’s Global Unique Device Identification Database

How to Manage the Different CAPA Phases

Auditing the Auditor

What is MedTech Lifecycle Excellence?

What is an ISO Audit?

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

Medical Device Clinical Trials: Regulatory Pathways & Study Types Explained

5 Steps For Effective Trial Design and Improved Compliance

The Best of Jon & Mike Through the Years

How to Verify and Validate SaMD in Different Stages

Most Popular Medical Device Content in 2022

Optimizing Generation of Clinical Evidence for Medical Devices

CDRH Proposed Guidance for FY 2023

Randomization in Medical Device Clinical Trials: Everything You Need to Know

A Year of Scale, Support, and Celebration

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

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

Greenlight Guru Hits the 1,000 Customer Milestone

A Letter From the CEO: Celebrating 1,000 Medical Device Customers

How to Use Greenlight Guru Clinical's ePRO Module

Electronic Data Capture for Medical Devices: Then vs. Now

Greenlight Guru Appoints Dan Thompson as Chief Sales Officer and Jeff Perkins as Chief Marketing Officer

The Future of Healthcare & How We Get There

How to Switch to eQMS Software When You're Just Using Paper

How ePRO Can Help Comply with EU MDR Post-Market Surveillance

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

Nonconformance (NC) and CAPA: When Should You Use Each Process?

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

Tracking Serious Adverse Events for Medical Devices (to Ensure GCP Compliance)

Developing a Regulatory Strategy

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?

We Achieved ISO Certification! Now what?

How to Integrate Complaint Handling and Risk Management

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies

The Future of Reprocessed Used Medical Equipment

The Difference Between Managing Product & Services Suppliers in MedTech

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

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

Customer Discovery for Medical Device Companies

Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR

EUA and the Impending Transition

Approved Supplier List: How To Add Suppliers to Your ASL in 7 Steps

3 Common Misconceptions About Medical Device Labeling

Medical Device QMS + Guru MedTech Experts: A Winning Combo for Global Market Success

10 Best Practices for eCRF in Medical Device Trials

Common QMS Mistakes SaMD Companies Make

15 Steps to Getting Approval for IEC 60601-1 (Staging)

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

Design Assurance: The Unsung Heroes of R&D

What You Need to Know About Risk Management and Using Post-Market Data

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?

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

Get Compliant Clinical Data with Investigator-Initiated Studies

Preparing for EUDAMED - Europe’s Medical Device Database

The Medical Device Practical Guide to PMCF Requirements under EU MDR

What is a Quality Culture? (and 7 Tips for Creating One)

3 Tips For Incorporating Risk Management During Medical Device Product Development

10 Tips for Selecting the Right EDC Software for Clinical Investigations

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

Four Years, For You

15 Steps to Getting Approval for IEC 60601-1

IEC 82304 vs IEC 62304: Software Standards for SaMD Explained

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

Compliant Adverse Event Reporting in Clinical Studies under the EU MDR

Best Practices for Clinical Evidence Management

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

Building Your Regulatory Strategy for Commercialization

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

Packaging Validation Best Practices

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

The Practical Guide to Post-Market Clinical Follow-up EU MDR Compliance

Explaining MDCG 2019-11: Software Qualification & Classification for MDR & IVDR

Bill of Materials (BOM) for Medical Devices: Everything You Need To Know

How to Design a Successful Post-Market Clinical Follow-Up (PMCF) Survey

Overcoming Submission Deficiencies due to Biocompatibility

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

Does Your CAPA Process Need a CAPA?

How the Design Control Process Applies to a 510(k) Premarket Notification

How to Use Queries for Monitoring Medical Device Studies in Greenlight Guru Clinical

UDI and the Current State of Global Implementation

Ultimate Guide to UDI for Medical Devices

Why Class 1 Medical Device Companies Need Design Controls (even if it’s not required)

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

How to Calculate Sample Size for Medical Device Studies

What are the Risk Management Documentation Requirements of ISO 14971?

3 ISO Compliance Guidelines Every Medical Device Manufacturer Should Follow

Digitizing your SaMD Testing

Why is Post-Market Surveillance Important for Medical Devices?

Why Training Compliance Matters for Pre-Market MedTech Companies

3 Common Problems with Design Controls (and the Solutions)

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

Downstream Effects of Inadequate Complaint Handling

What are the Distributor Requirements under EU MDR and IVDR?

Greenlight Guru Further Extends Commitment to Quality for Customers with Earning Both ISO 9001 and ISO 27001 Certifications

Guerilla Tactics for Quality Leadership

Selecting The Ideal PMCF Activity

3 Tips for Managing Your Medical Device Design History File

Preventing the Death of Medical Device Sales

5 Signs Your MedTech Startup is Ready for the Next Round of Funding

Shifting Sands of SaMD Cybersecurity Regulations

Understanding The Relationship Between Usability and Labeling of Your Medical Device

How To Apply a Risk-Based Approach to Biological Evaluation

Early Stage Territory Planning for Medical Device Companies

4 Letter to File Mistakes That Could Cost You

Striving for Excellence: G2 Ranks Greenlight Guru #1 in Best Support, Best Usability, and Best Results for QMS

Understanding Change Management and Change Control in the Medical Device Industry

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

Medical Device Companies - Top 100 in 2020 (Free Chart) (Clone)

3 Stages of Project Management in the Medical Device Industry & How to Navigate Each

Greenlight Guru Unveils the World's First MedTech Lifecycle Excellence Platform to Enable Success Across The Entire Product Lifecycle

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

MedTech Lifecycle Excellence: Out of the Dark and into the Age of Enlightened Quality

Recap of True Quality 2022

What Role Should Quality Play in Bringing a Medical Device to Market?

Early Feasibility Studies in Latin America

Who are the Economic Operators & What Does EU MDR Require of Them?

Applying for International Patents as a Medical Device Company

Greenlight Guru Acquires Electronic Data Capture Solution SMART-TRIAL

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

5 Strategies to Limit Project Timeline and Cost for your Medical Device

Approaching Cybersecurity & Usability as a SaMD Company

Setting up a Clinical Investigation under EU MDR

The Future of Lateral Flow Test Technology

Greenlight Guru Acquires AI/ML Consultancy Vertex Intelligence

Greenlight Guru Academy Advance: The Future of MedTech Learning is Continuous

Building a Culture of Quality

Bringing Medical Devices Into The Home

How to Build a Medical Device Business Case in 5 Easy Steps

FDA De Novo Pathway: Process Explained for Medical Device Companies

Demystifying the De Novo Process

Greenlight Guru Earns 2022 TrustRadius Top Rated Software Award

8 Questions That Define Your Medical Device User Needs

7 Tips to Attract Investors and Raise Funds for your Medical Device

Challenges for Regulatory Submission: EU vs. US

Performance Evaluation Under EU IVDR: Proving Your IVD’s Performance

From Startup to Industry Leader: LIVE RECORDING AT SCBIO CONFERENCE

30/60/90 Day Plan to Making an Impact as a New QA/RA Manager

The Future of Cybersecurity

Achieving Operational Readiness through Good Project Management

3 Tips for Planning a Successful Product Development Project for Your Medical Device

Bridging the Gap between Medical Devices and Clinical Data

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

How to Streamline the Customer Complaint Handling Process

MDSAP Approach - Navigating the Medical Device Single Audit Program

3 Common Misconceptions About Medical Device Packaging

30/60/90 Day Plan to Making an Impact as a Product Development Engineer

Bringing Augmented Reality MedTech to Market

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)

Making Your Informational Meetings with FDA Valuable & Worthwhile

Everything You Need to Know About Root Cause Analysis

The Clinical Evaluation Literature Review Process: Identifying and Appraising Clinical Data (Part 2 of 4)

Greenlight Guru Consistently Ranked as a Trusted Partner for Leading Medical Device Companies

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

Clinical Evaluation of a Medical Device: Creating a Process and Establishing Equivalency (Part 1 of 4)

4 Problems (and Solutions) for the Medical Device Supply Chain

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

FDA Inspections and ISO Audits: What is the Difference?

Understanding Technical Documentation in EU Regulations

Let The Document Tell The Story: Document Management Best Practices

How Medical Device Intellectual Property Protection Varies by Sector

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

Your Device is Non-Significant Risk: Now What?

The Five Themes of True Quality 2022

Greenlight Guru and Lexisnexis® Reed Tech Announce Strategic Alliance to Guide Customers to Market Faster

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

Software Bill of Materials: What to Know About SBOMs for Medical Devices

Survey Finds Fewer Than 3% of Pre-Market Medical Device Companies Are Very Effective at Measuring the Results of Quality Initiatives

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

How to Convince Your Boss to Send You to True Quality 2022

Greenlight Guru Expands Solution to Further Integrate Quality and Product Development Activities

Achieve Connected & Continuous Product Development: Introducing Greenlight Guru Products

How to Select a Contract Manufacturer

What Should Really Trigger a CAPA?

10 Reasons to Attend True Quality 2022

A Regulatory Gap Analysis of FDA's Systems & Policies

What You Need to Know About True Quality 2022

Greenlight Guru Announces True Quality 2022, Inaugural Conference for the Medical Device Industry

3 Medical Device Security Challenges (and Solutions)

How Do FDA Medical Device Recalls Work?

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

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

Understanding the Quality Control Process in Medical Device Manufacturing

ISO 11137: An Introduction to Gamma Sterilization Validation

Understanding the UDI System for Medical Devices

Best Practices for an Effective Medical Device Design Transfer Process

Most Popular Medical Device Content in 2021

Cytotoxicity Testing: Ensuring the Biocompatibility of Your Medical Device

Customers Rank Greenlight Guru As Leading QMS Software on G2 For 13th Consecutive Quarter

Shaking Things Up: What's Next for the Global Medical Device Podcast

Understanding Product Realization under ISO 13485:2016

UDI: Everything You Need to Know About Unique Device Identifiers for the FDA

What Does the IDE Application Process Involve?

How Augmented Reality (AR) is Revolutionizing Healthcare

Tips for Virtual Audits Your Medical Device Company Can Implement Today

Key Actions for Effective Medical Device Customer Complaint Handling

ISO 11607: A Primer on Packaging for Terminally Sterilized Medical Devices

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

Why Usability Matters

Transitioning to IVDR: The New EU Regulation for In Vitro Diagnostic Medical Devices

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

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

15 Items Medical Device Startups Need to Address

ISO 11135: An Overview of Medical Device Sterilization Using Ethylene Oxide

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?

What are the Top Compliance Issues Plaguing Medical Device Manufacturers?

Greenlight Guru and Formlabs Partner to Mitigate Risk and Accelerate Product Development in order to Improve Patient Outcomes

Competent Authority, Notified Body, ISO Registrar: How Each Role Functions in the Medical Device Industry

Setting the Record Straight on Usability & Human Factors

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

7 Project Management Tips

Project Management for Product Development of Medical Devices

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

Assessing the Global Regulatory Landscape

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

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 ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

When to Throw the Least Burdensome Flag on FDA

Creating a Quality Manual That Complies with ISO 13485

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

How to Execute a Successful Product Launch

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

Greenlight Guru Opens New Global Headquarters in Downtown Indianapolis

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

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

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

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

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

ISO 20417:2021 Replaces EN 1041: What You Need To Know

Driving MedTech Innovation with Safe and Effective Medical Devices

Meet a Guru: Maryann Mitchell

5 Biggest Quality Mistakes (And How You Can Avoid Making Them)

Why Storytelling Matters for Medical Device Companies

CEO of High-Growth Software Company Places Top 10 in the World in Elite Rowing Competition

5 Postmarket Surveillance System Musts for Every EU Manufacturer

A Breakthrough Device that Aims to Prevent Osteoporosis

3 Things Med Device Startups Must Do When Implementing a QMS

First-In-Class Diagnostics Tool Gets 510(k) Clearance Thanks to Greenlight Guru's QMS Software

Understanding FDA's New Intended Use Rule and its Implications

7 Documentation Musts for All Software Device Premarket Submissions

3 Life[cycle] Hacks for Integrating Risk Management throughout all Device Phases

Going from Weeks to Hours of Audit Prep Time for Easy ISO 13485 Certification

eQMS in Academia: Practical Learning for Biomedical Engineering Students

Understanding the Premarket Approval (PMA) Process

Tips for Running Better Management Reviews

How to Apply IEC 62304 Requirements for Medical Device Software

Understanding the FDA Medical Device Classification System

Meet a Guru: Ryan Behringer

Navigating the MedTech Cybersecurity Ecosystem

Choosing and Managing Your Medical Device Suppliers

Managing Clinical Data Activities

Explaining the Role of Importer under EU MDR

Understanding Intended Use from ISO TR 24971:2020

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

Centese Trades in Paper-based QMS for Greenlight Guru Quality & Achieves 510(k) Clearance

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

How the MDSAP Grading System Works

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

Greenlight Guru Announces Medical Device HQ Partnership

Greenlight Guru Receives Strategic Growth Investment from JMI Equity

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

Recruiting Top Medical Device Talent in a Competitive Market

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

Building your Brand as a Medical Device Professional

FDA QSR Transition to ISO 13485: Is Global Regulatory Harmonization on the Horizon?

Greenlight Guru Announces the Formation of Its New Regulatory Advisory Board

Understanding the Value of a Medical Device Guru

Meet a Guru: Etienne Nichols

5 Biggest Mistakes to Avoid when Seeking Funding for Your Medical Device

Meet a Guru: Laura Court

Regulatory Tips & Pointers from a Former FDA Reviewer

5 Tips to Improve your Medical Equipment Quality Assurance Activities

Answer These 3 Questions Before Developing Software as a Medical Device

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

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

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

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

Managing Business Risk as a Medical Device Company

How to Build Medical Device Usability Testing and Validation into Your Quality System

Waterfall vs. Agile: Battle of the Product Development Methodologies

For the Love of Internal Auditing

Preparing Your Abbreviated 510(k) Submission in 7 Easy Steps

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

5 Steps to Faster-to-Market, More Profitable Medical Devices

Knowing vs. Doing as Medical Device Professionals

Greenlight Guru Named Premier QMS Software for NIH RADx Initiative

Pivoting Operations to Meet PPE Demand during Pandemic

Pros & Cons of Being a Physician turned MedTech Inventor

What is a Quality Agreement for Medical Devices?

3 Systems of Risk for Medical Devices from FDA

Quality Management for IVD Devices vs Medical Devices

FDA Medical Device Labeling Requirements: Are You Complying?

Understanding the Investigational Device Exemption (IDE) Process

Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

How to Use the FDA ESG (Electronic Submissions Gateway)

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

3 Valuable Outcomes of a Culture of Quality

Meet a Guru: Sara Adams

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

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

What is a Traceability Matrix and How Do I Create One for My Medical Device?

Building a Startup in the MedTech Industry

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

Meet a Guru: Karen Schuyler

How to Demonstrate Substantial Equivalence in 5 Easy Steps

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

Everything you Need to Know about SaMD from an FDA Perspective

How to Use Voluntary Consensus Standards to your Strategic Advantage

Preparing for Remote and On-Site Inspections and Audits

How does EU MDR impact your Quality Management System?

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

Virtual Auditing in a Post-COVID World of Digital Compliance

Case Study: How Delta Development Fast-tracked R&D Down to 1 Year by Implementing a Medical Device QMS

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

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

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

Ultimate Guide to Training Management for Medical Device Companies

Prioritizing Medical Device Reimbursement During Product Development

Understanding ISO 13485 Training and Competency Requirements

5 Key Principles of Total Quality Management

5 Actionable Lessons Learned from the RADx Initiative by NIH

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

What are the Strategic Priorities for CDRH in 2021?

Change Management Process Explained in 6 Easy Steps (+ free template)

Understanding and Handling Different Types of Feedback

How to Use the De Novo Pathway for your Medical Device

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

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

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

Most Popular Medical Device Content in 2020 from Greenlight Guru

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

6 Benefits of the Best 21 CFR Part 11 Compliant Software

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

2021 State of Medical Device Quality Management and Product Development Benchmark Report

Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

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

What Goes into Designing Devices for Military and Emergency Applications?

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

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

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

Positive and Negative Impacts of EUA on the Medical Device Industry

Developing Pediatric Medical Devices: An Innovative Approach

Greenlight Guru Announces The 2021 State of Medical Device Virtual Summit

Why Biocompatibility Should be Addressed by Every Medical Device Company

Everything You Need to Know about Human Factors Engineering for Your Medical Device

Meet a Guru: Erica Loring

Free Complaint Template for Medical Devices

Free Template: Nonconformance Process for your Medical Device

Greenlight Guru Introduces Quality Event Automation to Advance Efficiencies in the Management of Post-Market Quality Events

What is a Multiple Function Device?

3 Reasons Why Closed-Loop Traceability is a QMS Must

Challenges related to Home Use Devices

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

519 Medical Device Manufacturers Reveal Biggest Barriers to Process Improvement

How Jon Speer Met His Most Frequent Guest: Mike Drues

Document Control for Medical Device Companies: The Ultimate Guide

Meet a Guru: Wade Schroeder

Unannounced Audits: A Survival Guide for Quality Managers

What are the Audit Etiquette Rules I Should be Following?

Meet a Guru: Tom Rish

How Do I Determine if my Product is a Medical Device?

Addressing Clinical Trial Challenges & Concerns during COVID-19

What is FDA's Approach to Regulating AI/ML in Software as a Medical Device?

Protecting the Intellectual Property of your Medical Device Technology

Meet a Guru: Jesseca Lyons

How to Escape the Lure of Legacy Quality Management Systems

How to Build a QMS for a Medical Device

Medical Device Reporting (MDR): How to Take Advantage of Your Electronic Records

Meet a Guru: Taylor Brown

How to Plan and Control the Design of your Medical Device while Meeting Regulatory Expectations

What is Regulatory Due Diligence for Medical Devices?

How to Validate Cloud-based Software Tools

Case Study: How Flexlogical Is Making Quality A Competitive Advantage By Adopting A Data-driven Approach With their Quality System

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

22 MedTech Experts Share Best Tips for Product Developers, QA/RA Professionals & Leadership Roles

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

EUA 101: What is Emergency Use Authorization and How can my Device get Authorized?

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

How COVID-19 is Impacting the Medical Device Industry: Data, Benchmarks & Trends

EU MDR Delay: How to Plan Beyond the Coronavirus Pandemic

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

Greenlight Guru and EMERGO by UL Announce Strategic Alliance to Simplify and Automate Global Market Access for Medical Device Companies

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

Documentation Priority for Early Stage Medtechs — Part 1: User Specification

How to Approach Verification and Validation for Cloud Software

How Software Architecture Enables Faster Release of New Clinical Tests to the Market

What are the Changes to ISO 14971:2019 & TR 24971?

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

COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health

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

How to Integrate Usability into your Medical Device

4 Emerging Trends in 2020 Backed by Medical Device Industry Experts

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

Only 6% of Device Makers Are Ready for EU MDR — Are You? Here are 3 Ways to Transition Now

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?

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

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

7 FDA Pathways to Bring Your Medical Device to Market

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

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

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

4 Parts to Interviewing Candidates for Medical Device Roles

Understanding Post-Market Surveillance Requirements for Medical Devices (US & EU Markets)

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

4 Major Reasons to Use Document Version Control Software for your Medical Device

The Art of Defining Design Inputs And Design Outputs

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?

3 Pros and Cons to 3D Printing for Medical Devices

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

Greenlight Guru Announces Enhanced Change Management Capabilities

How to Solve the Medtech Value Equation with Quality Data

FDA 21 CFR Part 820: 8 Most Common Mistakes to Avoid

Why Supplier Quality Management Is So Important

State of Medical Device Product Development and Quality Management Report 2020

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

Preparing for EU MDR

Tips for Success with IEC 60601 for Electrical Medical Devices

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

Passing MDSAP Audit & Getting FDA Approval Just Weeks After Implementing Greenlight Guru Quality

EU MDR Implementation Guide

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

Improving Outcomes and Reducing Costs with an Intelligent Surgical Medical Device

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

4 Biggest Challenges in Medical Device Manufacturing (and how to overcome them)

Leveraging Technology and Rapid Prototyping Methodologies during Product Development

Best Practices for Expediting Your Product Development

Why Design Verification Matters in Medical Device Design and Development

5 Tips from MedTech Executives on the Value of Quality

Implementing Changes to SaMD under New EU MDR

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

Why the FDA Pre-Submission is an Underutilized Tool

Right-sizing your QMS

How to Evaluate a Company’s Regulatory and Quality ‘Health’ Before Investing

Challenges with Pediatric Medical Devices

13 Tips For Audit Etiquette Every Medical Device Company Should Know

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

When Should You Start a QMS?

Ultimate Guide to Agile Design and Development for Medical Devices

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

A Firsthand Account of the Origins and Outcomes of FDA's Case For Quality and MDDAP

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

6 Most Common Mistakes When Implementing ISO 13485

Importance of Software Requirements in Product Development

How to Perform Effective Root Cause Analysis

Eliminating Subjectivity and Guesswork with a Modernized Solution to Detecting Ear Infections

4 Facts That May Surprise You About FDA

Should you Swipe Right or Left on your Notified Body?

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

Why I Used To Hate Risk Management (And 3 Ways to Change Your Mind Too)

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

Creating a Culture of Quality for Medical Device Companies

Enabling MedTech Innovation through Cross-functionality

FDA QSIT: Preparing Your Medical Device Company for an Inspection

Is Your Medical Device Company CAPA Happy?

10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]

Integrating Human Factors into Design Controls to Improve Patient Outcomes

5 Most Common Mistakes Made When Implementing ISO 14971

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

The Essential Guide to Preparing your QMS for EU MDR

Improving the Colon Cancer Screening Experience

EU MDR: Not All Doom and Gloom

Qualifying Your Suppliers Using a Risk-based Approach

Biocompatibility Nuances and its Impact on Medical Devices

How to Write Effective SOPs for Medical Devices

Advancing MRI Technology As We Know It Today

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

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

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

Greenlight Guru Launches New Podcast Series: MedTech True Quality Stories

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

ISO 13485 Medical Device Quality System Standard and Other Regulatory Conundrums

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

Why Document Control Matters To Medical Device Companies

Abbreviated 510(k): Substantial Equivalence Through Performance Criteria

The Greenlight Guru True Quality Roadshow: Atlanta Recap

Why Flexible Design Reviews Matter for Medical Device Product Development

Nonbinding Feedback is a New Guidance You Should Know About

Greenlight Guru Announces Digital Design Reviews for Medical Device Product Development Teams

How and When to Consider Human Factors

Quality, Fast, Cheap...Pick Two

Who Should Own Your QMS?

What to Expect During an FDA QSIT Inspection

Design Validation vs. Human Factors Validation

5 Most Common Problems with your CAPA Process

Medical Device Product Development Value Proposition

Introducing The Greenlight Guru True Quality Roadshow 2019

Best Practices for Effective Medical Device Design Reviews

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

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

Proactive Quality Systems: FDA Is Prioritizing Them...And You Should Too

Aligning True Quality and Compliance with MDDAP

Why Contract Manufacturers Shouldn't Own Your Quality System

Explaining the Significance of Voluntary Consensus Standards

FDA Case for Quality: 2018 Comprehensive Review

Medical Device Industry Predictions for 2019

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

FDA Computer System & Software Validation - What You’ve Known For 20+ Years Is Changing

Understanding the Blurred Lines Between Consumer Tech and MedTech

3 Real World Document Management Horror Stories

Understanding The Differences Between Clearance vs Approval vs Granted

Looking to join a fun, fast growing SaaS company? Greenlight Guru is hiring (Again)!

Top 20 Medical Device Venture Capital Firms

Streamlining The Device Marketing Authorization Process

13 Steps to Creating a Risk-Based CAPA Process

The New Special 510(k): What You Need To Know

5 Myths Engineers Believe About Quality (and what is really true)

What's New With PMAs

Greenlight Guru Announces New Integration with Jira Software

How To Drive Executive Engagement With Quality Systems (and actually get them excited about it)

How to Efficiently Raise Funds for Your Medical Device Company

Quality vs Compliance Metrics (and what's next for FDA's Case For Quality)

7 Habits of Highly Effective True Quality Medical Device Professionals

Regulatory Tips & Observations from a Former FDA Reviewer

FDA Aligning to ISO 13485:2016 (and Why It Matters)

Questions to Ask Before Hiring Your QA/RA Consultant

What it Means to be Focused on Quality vs. Compliance

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

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

Latest Updates on CDRH Standards Program and IEC 60601

The Importance of Good Document Management (And How To Do It)

Why the FDA Case for Quality Matters

15 Habits of Highly Effective Regulatory Professionals

How to Embrace Risk for Safer Devices

Greenlight Guru Announces Advanced Document Management

Scaling Regulatory and Quality with Your Company

What you need to know About FDA’s Progressive Programs

FDA Case for Quality Program: What, Why and How?

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

AI Explainability: What That Means and Why it Matters in Healthcare

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

Challenging “Conventional Wisdom” in Medtech R and D

How to Design for Compliance with IEC 60601

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

Why There is a Need for Multi-Level Design Controls

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

How a Partnership with Greenlight Guru Helped Rook Quality Systems Grow 15X in SIX Years

What Medical Device Developers Should Know About Human Factors

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

Creating an Effective Quality Culture that Benefits Your Patients

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

Sneak Peek Into the ISO 14971 Revision Process (From a Member of the Standard's Working Group, JWG1)

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

Greenlight Guru Announces Multi-Level Design Control Software

Helping to Prepare Biomedical Engineers Entering the Workforce

Competitive Regulatory Strategy vs. Regular Regulatory Strategy

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

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)

CAPA Process Mistakes You Want to Avoid

Understanding the New Requirements for QMS Software Validation in ISO 13485:2016

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

Quality Management Audit or Assessment?

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

4 Tips for Handling Nonconformances

Ultimate List of Medical Device Incubators and Accelerators (50+)

Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

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

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

What is Software as a Medical Device (SaMD)?

Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

Here Are the 4 Types of FDA Inspections You Need to Understand

Greenlight Guru Extends Platform with New Product, Grow, to Streamline PostMarket Quality Processes

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

Lessons to Be Learned from Recent FDA Inspections

How MEDDEV 2.7.1 Rev 4 Affects Medical Device Manufacturers

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

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

Why You Need To Stop Treating Risk Management & Design Controls as Checkbox Activities

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

The Do’s and Don’ts of an FDA Inspection

How to Translate Voice of Customer into User Needs

Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

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

How Process Excellence Leads to Product Excellence

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

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)

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

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

The Intersection of Medical Device Usability and Risk Management

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

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

EN ISO 14971:2012 Risk Assessment Explained in 5 Minutes… Using the Grossest Example Ever?

Fundamentals of Supplier Management for Medical Device Companies

An Overview of What Device Makers Need to Know About CAPA

5 Tips for Medical Device Engineers on FDA Design Controls

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

How to Speed up your Product Development Process

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

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

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

How Phagenesis Is Developing a Treatment for Dysphagia with Rebecca Sheridan

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

Using the Bucket Method for Medical Device Risk Management

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

The Business Case for Integrated Design Controls

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

Medical Device Risk – ISO 14971 Gets It Right

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

An Introduction to FDA 21 CFR Part 11

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

FDA 21 CFR Part 820 vs. ISO 13485:2016 vs. ISO 13485:2003

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

What's with the Rush to First-In-Human Studies?

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

Why Poor Design Controls Mean More Medical Device Complaints

Greenlight Guru Invited to Host Two Workshop Sessions at RAPS Convergence San Jose 2016

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

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

Why Use ISO 14971 vs. FMEA (Template Included)

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

What It Means to Join the Greenlight Guru Family

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

8 Reasons Why Your Design Controls And Risk Management Processes Fail

What Medtech Startups Should Know About Quality Systems To Not Go Overboard

Preparing Your Class II Device for the UDI Compliance Deadline with Reed Tech’s Gary Saner

5 Medical Device Project Management Tips That Will Help You Complete Your Project On Time

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

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

Tips to Help You Prepare for an FDA Inspection

Top 9 Reasons Device Makers Received FDA Form 483 and Warning Letters in 2015

Understanding Risk in Medical Device New Product Development (NPD)

How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

Is Your Company Disconnected from the Medical Device Regulations It Must Abide By?

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Medical Device Product Development Project Management Best Practices with Peter Sebelius

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

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

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out

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

The Greenlight Guru Advantage - More Than QMS Software [Customer Video Testimonial]

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

Why Getting FDA 510(k) Clearance Alone is Not Enough (And 6 Things You Can Do About It)

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

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

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

5 Reasons Why You Need To Implement a QMS or Bust

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

Greenlight Guru Wins 2015 Indiana Innovation Award

The Many Connotations Of Risk In Medtech Development — And The Consequences Of Getting Them Wrong

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

Does Your Medical Device Startup Suffer from CEO Disconnect Syndrome?

Risk Management from a Regulatory & Product Development Perspective [Podcast]

How To Flush $400,000 Down the Drain Fighting the FDA

How To Improve Your Design Reviews (Bonus Episode)

Design Reviews – Are More or Less Better?

A Brief Introduction to Medical Device Risk Management (Plus 5 Tips)

How To Improve Your Medical Device Design Reviews

How To Avoid a Medtech Documents & Records Scavenger Hunt

Join Us in Memphis for #ZeroToGreenlight - Why Worrying About FDA Regulations Matters

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

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

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Changing Medical Device Design Control

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Key Considerations for Implementing Post-Market Clinical Follow-Up for Medical Devices

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Complaint Log + Form Template Bundle

Greenlight Guru Clinical & BSI Life Sciences: Live Demo Integration

Maximizing Value from Design Controls: Strategies for Medical Device Companies

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EU MDR Hot Takes: Evolution or Overreach?

Live with FDA: Accelerating a Quality Culture at Your Medical Device Company

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Verification Protocol Template

2024 MedTech Path to Market True Quality Summit Series

Global UDI Updates: Navigating EUDAMED Changes & Health Authority Trends

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Ultimate Guide to Device Class Requirements under EU MDR

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GSPR Template

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Medical Devices Essential Principles Checklist

IEC 62366-1 Essentials: Elevating User Safety in Medical Devices

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ISO 14971 Risk Management for Medical Devices: The Definitive Guide

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Clinical Investigation Plan (CIP) Synopsis Template

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Resource Bundle for Risk Managers

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FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist

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Align Your Clinical Claims Webinar Q&A

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Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

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

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Clinical Evaluation Toolkit

15 Reasons Why Medical Device Companies Choose Greenlight Guru

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HTD Health Chooses Greenlight Guru Quality for a Modern, SaMD-Friendly eQMS

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MDR & IVDR Gap Analysis Toolkit

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Implementing Risk Throughout the Entire Product Lifecycle

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What to Include in Your Quality Assurance Agreement with a Distributor

Oticon Medical Continues Striving for Clinical Excellence

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Monarch Medical Makes Sense of Document Management With Greenlight Guru Quality

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QMS Implementation Checklist Template

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Quality Management System (QMS) Software Vendor Checklist

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

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

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MDR Compliant Prospective & Retrospective Clinical Studies

Complete Guide to Bringing a Medical Device to Market

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

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15-in-1 MedTech Template Bundle

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Top 30 MDCG Guidance Documents for Medical Device Companies

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Top 40 IMDRF Technical Documents for Medical Devices

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MDD vs. MDR Gap Assessment Tool

21 CFR Part 11: A Complete Guide

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5 Tips for IEC 60601 Submissions

HEMEX Leverages Greenlight Guru Clinical to Help Clients Collect High-Quality Clinical Data More Efficiently

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MDR by the Numbers: Leveraging New Data for Implementation Planning

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

PSA Flanders Uses Greenlight Guru Clinical and Gets Exceptionally High Response Rates to their Survey

2023 State of Medical Device True Quality Summit Series

MedTech Industry Benchmark Report

Chelsea and Westminster Hospital Leverages Greenlight Guru Clinical for Intuitive eCRFs and Fast Study Setup

InnoCon Medical Chooses Greenlight Guru Clinical for a Modern, Streamlined EDC Solution

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

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

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Mastering the Design Transfer Process

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How to Plan a Clinical Data Management Setup for EDC Systems

How to Plan a Clinical Data Management Setup for EDC Systems

World Leader in Regenerating Damaged Human Tissues Uses Greenlight Guru Clinical

Smarter Renal Care Trials with Greenlight Guru Clinical

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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?

European IVD Startup Gets Fast, Accurate Clinical Data

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

The Future of QMS Requirements True Quality Summit Series

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Medical Device Reporting (MDR) Decision Tree

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EU MDR Gap Analysis Tool

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2021 Risk Management True Quality Summit Series

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

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7 Principles to Designing an eCRF

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Ultimate Guide to UDI for Medical Devices

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The Medical Device Sample Size Cookbook

Raising Capital True Quality Summit Series

Selecting the Ideal PMCF Activity

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

Loop Medical Switched from Paper and Got Real-Time Access to Data with Greenlight Guru Clinical

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

How to Prepare for the FDA Pre-Submission Process - Free Webinar

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CAPA Report Template

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5 Tips for a Successful 510(k) Submission

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10 Resources to Get Medical Device Companies on Track

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6 Tips for a Seamless Document Migration to Greenlight Guru

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Clinical Evaluation Procedure Template

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Quality Event Template Package for CAPAs, Complaints & Nonconformities

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True Quality 2022

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Periodic Safety Update Report Template

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10 Ways A Modern, Cloud-Based Medical Device QMS Helps Remote Teams Stay Ahead

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Free Replay Package: 2021 Medical Device Virtual Summit

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Change Impact Analysis Template

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Total Quality Management 4-in-1 Tool

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5 Tips for Using a Predicate Device

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5 Ways to Prepare Your Team for an FDA Inspection

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Cheat Sheet on Preparing Your Team for an FDA Inspection

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Suggested Quality Domain Metrics

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Failure Mode Effects Analysis (FMEA) Template

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ISO 13485:2016: Changes You Should Know About

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8 Quick Facts about CAPA Cheat Sheet

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5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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4 Methods for Root Cause Analysis Cheat Sheet

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9 Tips for Password Compliance with 21 CFR Part 11

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Clinical Evaluation in the EU for Medical Devices: Understanding the Changes in MEDDEV 2.7.1 Rev 4 and Their Impact

Recovery Force Accelerates Their Product Development Efforts Using Greenlight Guru [Case Study]

FDA 510(k) Submission Tips, Tricks and Timelines from a Former FDA Reviewer [Free Webinar]

How to Prepare for the New EU Medical Device Regulations (MDR) [Free Webinar]

How to Prepare for the New EU In Vitro Diagnostic Regulations (IVDR) [Free Webinar]

8 Steps You Should Be Taking to Implement an EU-MDR Compliance Program [Free Webinar]

15 Steps to Get Approval to IEC 60601-1 [Free Webinar]

How to Simplify Compliance to the new ISO 13485:2016 Quality Management Standard - Webinar

FDA 483 and Warning Letters: How to Avoid and Respond - Webinar

Risk Management for Medical Devices - Webinar

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

Real-World Data and Real-World Evidence: When and How to Use Them

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

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CHECKLIST/TEMPLATE

17 resources bundled into 1 free download for product developers to accelerate bringing a device to market.

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Product Development

Explore valuable insights and best practices in product development for medical devices.

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eBook

Complete Guide to Bringing a Medical Device to Market

eBook

The Ultimate Guide To Design Controls For Medical Device Companies

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eBook

Learn what is expected from regulators & how to leverage risk as a tool with this comprehensive guide.

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Risk Management

Explore valuable insights and best practices in risk management for medical devices.

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eBook

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

Checklist/Template

ISO 14971:2019 Gap Analysis Tool

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CHECKLIST/TEMPLATE

This content bundle is packed with resources tailored specifically to help medical device companies run efficient clinical investigations while ...

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Clinical Data Collection & Management

Explore valuable insights and best practices in clinical data collection and management for medical devices.

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eBook

Electronic Data Capture Buyer’s Guide: Making the Business Case for a New EDC System

eBook

Ultimate Guide to Clinical Data Management in MedTech

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eBook

A guide to breaking down the different options your medical device company has for a QMS solution and help you make an informed decision that’s ...

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Featured Collection

Quality Management

Explore valuable insights and best practices in quality management for medical devices.

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eBook

ISO 13485 for Medical Devices QMS - The Ultimate Guide

eBook

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

Webinars

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Upcoming

October 24, 2024

Integrating Risk Management & CAPA: How to Supercharge Your Medical Device Quality

Join us for an insightful webinar led by Kyle Rose, CEO of Rook Quality Systems, as he explores the critical connection between risk management and CAPA, and how to integrate these functions to proactively mitigate risks, prevent future nonconformities, and elevate the overall effectiveness of your QMS.

On Demand

October 15, 2024

Clinical Submission Do's & Don’ts: Tips from a Former Notified Body Expert

In this free webinar, Dr Yvonne Ndefo, former Chief Clinical Evaluator at NSAI, shares key insights on how to create robust clinical submissions that satisfy Notified Bodies' rigorous requirements.

September 19, 2024

Key Considerations for Implementing Post-Market Clinical Follow-Up for Medical Devices

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October 03, 2024

How to Best Prepare for FDA QMSR

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Post-market Surveillance

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Webinar

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

During this free 60 minute webinar hosted by Carolyn Guthrie, Director of QA/RA at Kapstone Medical, you will learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.

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Ultimate Guide to Postmarket Surveillance of Medical Devices

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Selecting the Ideal PMCF Activity

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Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

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Audits & Inspections

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FDA QSIT: Preparing Your Medical Device Company for an Inspection

If you prepare well in advance of an inspection, not only can you reduce these fears, but you can find that your company can actually reap many benefits.

13 Tips For Audit Etiquette Every Medical Device Company Should Know

Learn proven and effective tips and pointers for preparing for an audit and ensuring it runs smoothly from a certified Lead Auditor for ISO 13485.

The Ultimate Internal Audit Checklist Every Medical Device Company Needs

The ultimate internal audit checklist you can begin using today to ensure every system, process, & operation associated with your device is performing at its best.

The Definitive Guide to Responding to FDA 483 Observations and Warning Letters

A detailed guide regarding exactly how to respond to FDA 483 observations and warning letters.

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Global Medical Device Podcast

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Determining User Needs for Your Medical Device

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Understanding the ROI of an eQMS

In this episode we explore the return on investment of a purpose-built electronic Quality Management System ...

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Regulatory Strategy and the Advantage of Diversity in MedTech

This episode covers crucial topics such as biases in medical device testing, evolving FDA approaches, and the ...

Most Recent Resources

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Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

This episode offers a unique perspective on navigating FDA inspections, building robust quality systems, and managing innovation within the MedTech industry.

Integrating Risk Management & CAPA: How to Supercharge Your Medical Device Quality

Why Your Company Needs a QMS Software or eQMS

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Market Access vs Adoption: Why Your Class II Device Needs Clinical Evidence

Focus on the Work That Matters Most.

See how Greenlight Guru’s MedTech Suite can help you eliminate the repetitive, low-value tasks of your day-to-day with a personalized demo.

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