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Why Your Company Needs a QMS Software or eQMS

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A Free CAPA Template for the Medical Device Industry

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

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Top 100 Medical Device Acronyms & Terminology You Need to Know

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

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How to Carry Out PMCF Activities According to EU MDR

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

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Definitive Guide to Change Management for Medical Devices

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

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

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

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

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

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

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IVDR for In Vitro Diagnostic Medical Device Companies - Ultimate Guide

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

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

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How To Approach Supplier Corrective Action Requests (SCAR)

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Engineering Change Order: Its Role in the Change Management Process

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How to Structure a Clinical Investigation Report (CIR) Summary

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

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Boost Efficiency and Decision-Making with Enhanced Clinical Data Reporting

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How to Improve Detecting, Correcting, and Preventing Nonconformances

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

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Identifying and Evaluating Medical Device Importers

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How to Develop a Risk-Based Approach to Supplier Management

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Alternatives to PMCF Clinical Investigations

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How to Manage Complex Downstream Design Changes to Your Medical Device

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

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Understanding ISO 14971 Medical Device Risk Management

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

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3 Things to Love about Internal Audits

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

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5 Tips for Running Effective Internal Quality Audits

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eBOM vs mBOM: What’s the Difference?

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Medical Device Adverse Event Reporting Regulations: EU vs. US

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How to Handle Medical Device Adverse Events

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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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Ultimate Guide to Postmarket Surveillance of Medical Devices

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7 Essential Steps of a Nonconformance Report

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

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

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

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

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

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

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

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9 Steps to Creating a CAPA Audit Checklist

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

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5 Steps For Effective Trial Design and Improved Compliance

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

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Design Controls Need to Start With User Needs

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How to Use Greenlight Guru Clinical's ePRO Module

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

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

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How Does the EU GDPR Impact Medical Device Clinical Trials?

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How to Integrate Complaint Handling and Risk Management

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MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

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

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

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Should ISO 15189 Certification Matter to Medical Device Companies?

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

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The Medical Device Practical Guide to PMCF Requirements under EU MDR

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10 Tips for Selecting the Right EDC Software for Clinical Investigations

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Compliant Adverse Event Reporting in Clinical Studies under the EU MDR

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eCRF Template for Clinical Investigations and PMCF Studies

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

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Why is Post-Market Surveillance Important for Medical Devices?

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3 Common Problems with Design Controls (and the Solutions)

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What are the Distributor Requirements under EU MDR and IVDR?

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Selecting The Ideal PMCF Activity

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3 Tips for Managing Your Medical Device Design History File

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Understanding Change Management and Change Control in the Medical Device Industry

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

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How to Streamline the Customer Complaint Handling Process

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Everything You Need to Know About Root Cause Analysis

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

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What Should Really Trigger a CAPA?

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Tips for Virtual Audits Your Medical Device Company Can Implement Today

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Key Actions for Effective Medical Device Customer Complaint Handling

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Software as a Medical Device: Definitions, Examples & Regulatory Framework

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

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

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How to Assess the Impact of Any Change to your Medical Device (+ Free Checklist)

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Top 3 Reasons for FDA 483 Observations in 2020

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

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5 Postmarket Surveillance System Musts for Every EU Manufacturer

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7 Documentation Musts for All Software Device Premarket Submissions

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Choosing and Managing Your Medical Device Suppliers

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How the MDSAP Grading System Works

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What is a Quality Agreement for Medical Devices?

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

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

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5 Key Principles of Total Quality Management

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

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Free Complaint Template for Medical Devices

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Free Template: Nonconformance Process for your Medical Device

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

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3 Reasons Why Closed-Loop Traceability is a QMS Must

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Document Control for Medical Device Companies: The Ultimate Guide

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Unannounced Audits: A Survival Guide for Quality Managers

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How to Escape the Lure of Legacy Quality Management Systems

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

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

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

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

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

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

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

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

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Greenlight Guru Announces Enhanced Change Management Capabilities

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

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Best Practices for Expediting Your Product Development

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13 Tips For Audit Etiquette Every Medical Device Company Should Know

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How to Perform Effective Root Cause Analysis

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FDA QSIT: Preparing Your Medical Device Company for an Inspection

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Qualifying Your Suppliers Using a Risk-based Approach

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5 Most Common Problems with your CAPA Process

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3 Real World Document Management Horror Stories

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13 Steps to Creating a Risk-Based CAPA Process

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

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

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Quality Management Audit or Assessment?

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4 Tips for Handling Nonconformances

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Standard Conformity or Regulatory Compliance? Distinguishing the Two

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What Does a Risk-Based QMS Mean?

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

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How to Retroactively Create Design Controls and DHF (Even Though You Should Never Let This Happen)

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Debunking 8 Commonly Held CAPA Myths

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13 Common Pitfalls to Avoid During Medical Device Product Development

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Better Root Cause Analysis for Safer, More Effective Medical Devices

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CAPA: When to Take Corrective Action or Preventive Action?

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What is a “Quality Data Source” for your CAPA Process?

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Tips for Conducting Better Root Cause Analysis for Medical Device Companies

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Fundamentals of Supplier Management for Medical Device Companies

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4 Key Compliance Issues for Medical Device Companies

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What is CAPA in the Medical Device Industry?

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Why Poor Design Controls Mean More Medical Device Complaints

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4 Medical Device Quality System Musts for Startups

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4 Lessons I Learned Going Through an FDA / ISO Audit for the First Time as an Engineer

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How To Reduce & Prevent Medical Device Complaints

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

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