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Checklists & Templates

Tips, checklists, and templates from seasoned medical device professionals available at your fingertips.

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Checklists and Templates

ISO 14971:2019 Gap Analysis Tool

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Checklists and Templates

15-in-1 MedTech Template Bundle

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Checklists and Templates

General Safety and Performance Requirements (GSPR) Gap Assessment

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Checklists and Templates

5 Tips for IEC 60601 Submissions

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EU MDR Economic Operators Guidance Document

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Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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CAPA Report Template

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Checklists and Templates

Quality Event Template Package for CAPAs, Complaints & Nonconformities

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Clinical Evaluation Procedure Template

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Checklist to Evaluate Your Quality Control Process

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Design Transfer to Manufacturing

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Medical Device Reporting (MDR) Decision Tree

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Checklists and Templates

How To Prepare An FDA Pre-Submission

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Checklists and Templates

Periodic Safety Update Report Template

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Checklists and Templates

Abbreviated 510(k) Submission Checklist

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Checklists and Templates

Checklist For Selecting Suppliers + Contract Manufacturers

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Checklists and Templates

FDA Labeling Requirements Checklist

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Checklists and Templates

Checklist: Premarket Submission Documentation for Devices Containing Software

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Checklist for Structuring Your Technical Documentation

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Approved Supplier List Form Template

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Clinical Investigation Report Checklist

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Checklists and Templates

6 Tips for a Seamless Document Migration to Greenlight Guru

"Greenlight Guru provides an Electronic Quality Management System (eQMS) for medical device companies to ensure quality standards are met without requiring that the end ...

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Checklists and Templates

Content Toolkit for Medical Device Startups

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Checklists and Templates

MDR & IVDR Gap Analysis Toolkit

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5 Steps for Creating a Traceability Matrix

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Medical Device Project Plan

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Checklists and Templates

510(k) Program Comparison Chart

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Checklists and Templates

Total Quality Management 4-in-1 Tool

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Checklists and Templates

Legacy vs Best-in-Class QMS Tools Comparison Chart

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Checklists and Templates

Change Impact Analysis Template

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Checklists and Templates

Change Order Template

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Nonconformance Report Template

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Checklists and Templates

Free Replay Package: 2021 Medical Device Virtual Summit

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Checklists and Templates

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

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Checklists and Templates

Value of True Quality Infographic

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Training Matrix Template

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Checklists and Templates

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

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Biocompatibility Testing Selection Criteria

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Human Factors & Usability Engineering Report

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Complaint Template

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CAPA Template

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Checklists and Templates

7 Steps for Writing a Nonconformance Report

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3 Tips for Receiving EUA from FDA

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

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IVDR Gap Assessment Tool

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MDD vs. MDR Gap Assessment Tool

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Checklists and Templates

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

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Content Toolkit for Medical Device Executive Leaders

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Checklists and Templates

Content Toolkit for Medical Device QA/RA Professionals

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Checklists and Templates

Content Toolkit for Medical Device Product Developers

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Checklists and Templates

Quality Culture Flowchart

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Checklists and Templates

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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Checklists and Templates

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

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Checklists and Templates

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

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Checklists and Templates

EU MDR Gap Analysis Tool

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Checklists and Templates

Suggested Quality Domain Metrics

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Compliance or Quality Focused Comparison Chart

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Checklists and Templates

What Influences SaMD Classification?

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Checklists and Templates

Benefits of a Formal Document Management Solution

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5 FDA 510(k) Submission Mistakes to Avoid

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Checklists and Templates

What Medical Device Investors Want to See Checklist

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Checklists and Templates

FDA Program Comparison Table

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Checklists and Templates

4 Cornerstones of an Effective eQMS

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Checklists and Templates

6 Ways AI is Transforming Healthcare

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Checklists and Templates

Top 100 Medical Device Companies in the World Chart

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Checklists and Templates

5 Practical R&D Tips for Medical Device Developers

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10 Key Questions for Defining User Needs

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Checklists and Templates

7 Tips for Incorporating Human Factors into Device Design

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Checklists and Templates

Tips to Building Consistent QMS Procedures

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5 Tips for a Competitive Regulatory Strategy

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Checklists and Templates

5 Tips for Better DHF Management Cheat Sheet

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Checklists and Templates

Most Common Sources of Post-market Surveillance Data

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Checklists and Templates

15 Steps to Create a Risk-based CAPA Process Infographic

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Checklists and Templates

Ultimate List of Medical Device Incubators & Accelerators

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Checklists and Templates

4 Steps to Gathering Accurate Complaint Data

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Checklists and Templates

Overview of a Customer Complaint-handling Procedure

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Checklists and Templates

Guide to When to Use Different Tools for CAPA Analysis

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Checklists and Templates

FDA 483 & Warning Letter Checklist

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Checklists and Templates

510(k) Submission Checklist

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Checklists and Templates

Cheat Sheet on Preparing Your Team for an FDA Inspection

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Checklists and Templates

7 Signs You're Ready for an eQMS

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Checklists and Templates

5 Ways to Prepare Your Team for an FDA Inspection

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Checklists and Templates

Using Your 510(k) Submission for Design Controls and DHF Table

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Checklists and Templates

5 Tips for Using a Predicate Device

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Checklists and Templates

4 Signs You Need to Issue a CAPA

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Checklists and Templates

Key Elements of Your Design History File Checklist

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Checklists and Templates

10 Resources to Get Medical Device Companies on Track

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Checklists and Templates

5 Key Steps for Getting Your Medical Device CE Mark

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Checklists and Templates

Sample Management Review Template

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Checklists and Templates

Tips to Help Define User Needs

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Checklists and Templates

4 Helpful Tips for Better Management of Your Design History File

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Checklists and Templates

9 Tips for Password Compliance with 21 CFR Part 11

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Checklists and Templates

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

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What FDA Expects to See as Part of Your CAPA Process Cheatsheet

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5 Step Checklist to Determine If a CAPA Is Required

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Checklists and Templates

Checklist for Selecting Suppliers to Your Medical Device Company

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Checklists and Templates

4 Methods for Root Cause Analysis Cheat Sheet

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Checklists and Templates

7 Rules for Effective Medical Device Design Controls Cheat Sheet

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Checklists and Templates

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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Checklists and Templates

5 Tips for a Successful 510(k) Submission

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Checklists and Templates

8 Quick Facts about CAPA Cheat Sheet

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Checklists and Templates

ISO 13485:2016: Changes You Should Know About

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Checklists and Templates

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

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Checklists and Templates

Failure Mode Effects Analysis (FMEA) Template

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Checklists and Templates

Medical Device Product Development Checklist

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Checklists and Templates

FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

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Checklists and Templates

FDA 483/Warning Letter Response Template

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Checklists and Templates

Risk Management Plan Template

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Checklists and Templates

5 Tips to Help your FDA 510(k) Submission

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