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Ultimate Guide to Comparing Quality Management System Solutions

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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Checklists & Templates

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

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Complaint Form Template
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Complaint Form Template

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How to Clear a Software Medical Device
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How to Clear a Software Medical Device

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FDA Pre-Submission Meeting Checklist
Checklists and Templates

FDA Pre-Submission Meeting Checklist

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GSPR Template
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GSPR Template

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Medical Devices Essential Principles Checklist
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Medical Devices Essential Principles Checklist

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MDSAP QMS Audit Checklist
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MDSAP QMS Audit Checklist

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Clinical Investigation Plan (CIP) Synopsis Template
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Clinical Investigation Plan (CIP) Synopsis Template

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Resource Bundle for Risk Managers
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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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FDA QSR, QMSR & ISO 13485:2016 Internal Audit Checklist

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Premarket Approval Inspection Checklist
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Premarket Approval Inspection Checklist

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Cybersecurity Gap Assessment Checklist
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Cybersecurity Gap Assessment Checklist

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FDA QMSR & ISO 13485:2016 QMS Internal Audit Checklist
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FDA QMSR & ISO 13485:2016 QMS Internal Audit Checklist

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Align Your Clinical Claims Webinar Q&A
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Align Your Clinical Claims Webinar Q&A

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ChatGPT Sample Prompts for Risk Evaluation of a Medical Device
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ChatGPT Sample Prompts for Risk Evaluation of a Medical Device

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Validation Toolkit
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Validation Toolkit

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Class 3 Medical Device Content Bundle
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Class 3 Medical Device Content Bundle

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Class 2 Medical Device Content Bundle
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Class 2 Medical Device Content Bundle

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Class 1 Medical Device Content Bundle
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Class 1 Medical Device Content Bundle

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Clinical Evaluation Toolkit
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Clinical Evaluation Toolkit

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Checklist for Protecting your IP throughout the MedTech Lifecycle
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Checklist for Protecting your IP throughout the MedTech Lifecycle

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What to Include in Your Quality Assurance Agreement with a Distributor
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What to Include in Your Quality Assurance Agreement with a Distributor

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QMS Implementation Checklist Template
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QMS Implementation Checklist Template

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Quality Management System (QMS) Software Vendor Checklist
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Quality Management System (QMS) Software Vendor Checklist

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ISO 14971:2019 Gap Analysis Tool
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ISO 14971:2019 Gap Analysis Tool

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15-in-1 MedTech Template Bundle
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15-in-1 MedTech Template Bundle

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General Safety and Performance Requirements (GSPR) Gap Assessment
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General Safety and Performance Requirements (GSPR) Gap Assessment

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5 Tips for IEC 60601 Submissions
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5 Tips for IEC 60601 Submissions

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EU MDR Economic Operators Guidance Document
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EU MDR Economic Operators Guidance Document

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5
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5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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CAPA Report Template
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CAPA Report Template

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Quality Event Template Package for CAPAs, Complaints & Nonconformities
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Quality Event Template Package for CAPAs, Complaints & Nonconformities

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Clinical Evaluation Procedure Template
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Clinical Evaluation Procedure Template

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Checklist to Evaluate Your Quality Control Process
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Checklist to Evaluate Your Quality Control Process

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Design Transfer to Manufacturing
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Design Transfer to Manufacturing

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Medical Device Reporting (MDR) Decision Tree
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Medical Device Reporting (MDR) Decision Tree

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How To Prepare An FDA Pre-Submission
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How To Prepare An FDA Pre-Submission

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Periodic Safety Update Report Template
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Periodic Safety Update Report Template

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Abbreviated 510(k) Submission Checklist
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Abbreviated 510(k) Submission Checklist

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Checklist For Selecting Suppliers + Contract Manufacturers
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Checklist For Selecting Suppliers + Contract Manufacturers

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FDA Labeling Requirements Checklist
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FDA Labeling Requirements Checklist

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Checklist: Premarket Submission Documentation for Devices Containing Software
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Checklist: Premarket Submission Documentation for Devices Containing Software

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Checklist for Structuring Your Technical Documentation
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Checklist for Structuring Your Technical Documentation

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Approved Supplier List Form Template
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Approved Supplier List Form Template

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Clinical Investigation Report Checklist
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Clinical Investigation Report Checklist

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6 Tips for a Seamless Document Migration to Greenlight Guru
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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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Content Toolkit for Medical Device Startups
Checklists and Templates

Content Toolkit for Medical Device Startups

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MDR & IVDR Gap Analysis Toolkit
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MDR & IVDR Gap Analysis Toolkit

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5 Steps for Creating a Traceability Matrix
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5 Steps for Creating a Traceability Matrix

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Medical Device Project Plan
Checklists and Templates

Medical Device Project Plan

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510(k) Program Comparison Chart
Checklists and Templates

510(k) Program Comparison Chart

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Total Quality Management 4-in-1 Tool
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Total Quality Management 4-in-1 Tool

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Legacy vs Best-in-Class QMS Tools Comparison Chart
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Legacy vs Best-in-Class QMS Tools Comparison Chart

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Change Impact Analysis Template
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Change Impact Analysis Template

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Change Order Template
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Change Order Template

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Nonconformance Report Template
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Nonconformance Report Template

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Free Replay Package: 2021 Medical Device Virtual Summit
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Free Replay Package: 2021 Medical Device Virtual Summit

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

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Value of True Quality Infographic
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Value of True Quality Infographic

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Training Matrix Template
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Training Matrix Template

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

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Biocompatibility Testing Selection Criteria
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Biocompatibility Testing Selection Criteria

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Human Factors & Usability Engineering Report
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Human Factors & Usability Engineering Report

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Complaint Template
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Complaint Template

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7 Steps for Writing a Nonconformance Report
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7 Steps for Writing a Nonconformance Report

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3 Tips for Receiving EUA from FDA
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3 Tips for Receiving EUA from FDA

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

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IVDR Gap Assessment Tool
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IVDR Gap Assessment Tool

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MDD vs. MDR Gap Assessment Tool
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MDD vs. MDR Gap Assessment Tool

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5 Myths about PMA's (and what's actually true)
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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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Content Toolkit for Medical Device Executive Leaders

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Content Toolkit for Medical Device QA/RA Professionals
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Content Toolkit for Medical Device QA/RA Professionals

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Content Toolkit for Medical Device Product Developers
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Content Toolkit for Medical Device Product Developers

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Quality Culture Flowchart
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Quality Culture Flowchart

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EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool
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EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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

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MDSAP vs. ISO 13485:2016 Gap Assessment Tool
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MDSAP vs. ISO 13485:2016 Gap Assessment Tool

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EU MDR Gap Analysis Tool
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EU MDR Gap Analysis Tool

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Suggested Quality Domain Metrics
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Suggested Quality Domain Metrics

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Compliance or Quality Focused Comparison Chart
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Compliance or Quality Focused Comparison Chart

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What Influences SaMD Classification?
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What Influences SaMD Classification?

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Benefits of a Formal Document Management Solution
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Benefits of a Formal Document Management Solution

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5 FDA 510(k) Submission Mistakes to Avoid
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5 FDA 510(k) Submission Mistakes to Avoid

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What Medical Device Investors Want to See Checklist
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What Medical Device Investors Want to See Checklist

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FDA Program Comparison Table
Checklists and Templates

FDA Program Comparison Table

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4 Cornerstones of an Effective eQMS
Checklists and Templates

4 Cornerstones of an Effective eQMS

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6 Ways AI is Transforming Healthcare
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6 Ways AI is Transforming Healthcare

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Top 100 Medical Device Companies in the World Chart
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Top 100 Medical Device Companies in the World Chart

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5 Practical R&D Tips for Medical Device Developers
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5 Practical R&D Tips for Medical Device Developers

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10 Key Questions for Defining User Needs
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10 Key Questions for Defining User Needs

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7 Tips for Incorporating Human Factors into Device Design
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7 Tips for Incorporating Human Factors into Device Design

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Tips to Building Consistent QMS Procedures
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Tips to Building Consistent QMS Procedures

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5 Tips for a Competitive Regulatory Strategy
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5 Tips for a Competitive Regulatory Strategy

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5 Tips for Better DHF Management Cheat Sheet
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5 Tips for Better DHF Management Cheat Sheet

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Most Common Sources of Post-market Surveillance Data
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Most Common Sources of Post-market Surveillance Data

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15 Steps to Create a Risk-based CAPA Process Infographic
Checklists and Templates

15 Steps to Create a Risk-based CAPA Process Infographic

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Ultimate List of Medical Device Incubators & Accelerators
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Ultimate List of Medical Device Incubators & Accelerators

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4 Steps to Gathering Accurate Complaint Data
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4 Steps to Gathering Accurate Complaint Data

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Overview of a Customer Complaint-handling Procedure
Checklists and Templates

Overview of a Customer Complaint-handling Procedure

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Guide to When to Use Different Tools for CAPA Analysis
Checklists and Templates

Guide to When to Use Different Tools for CAPA Analysis

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FDA 483 & Warning Letter Checklist
Checklists and Templates

FDA 483 & Warning Letter Checklist

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510(k) Submission Checklist
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510(k) Submission Checklist

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Cheat Sheet on Preparing Your Team for an FDA Inspection
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Cheat Sheet on Preparing Your Team for an FDA Inspection

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7 Signs You're Ready for an eQMS
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7 Signs You're Ready for an eQMS

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5 Ways to Prepare Your Team for an FDA Inspection
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5 Ways to Prepare Your Team for an FDA Inspection

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

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

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5 Tips for Using a Predicate Device
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5 Tips for Using a Predicate Device

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4 Signs You Need to Issue a CAPA
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4 Signs You Need to Issue a CAPA

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Key Elements of Your Design History File Checklist
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Key Elements of Your Design History File Checklist

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10 Resources to Get Medical Device Companies on Track
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10 Resources to Get Medical Device Companies on Track

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5 Key Steps for Getting Your Medical Device CE Mark
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5 Key Steps for Getting Your Medical Device CE Mark

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Sample Management Review Template
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Sample Management Review Template

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Tips to Help Define User Needs
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Tips to Help Define User Needs

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4 Helpful Tips for Better Management of Your Design History File
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4 Helpful Tips for Better Management of Your Design History File

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9 Tips for Password Compliance with 21 CFR Part 11
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9 Tips for Password Compliance with 21 CFR Part 11

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4 Reasons the Root Cause Isn't
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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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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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5 Step Checklist to Determine If a CAPA Is Required

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Checklist for Selecting Suppliers to Your Medical Device Company
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Checklist for Selecting Suppliers to Your Medical Device Company

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4 Methods for Root Cause Analysis Cheat Sheet
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4 Methods for Root Cause Analysis Cheat Sheet

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7 Rules for Effective Medical Device Design Controls Cheat Sheet
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7 Rules for Effective Medical Device Design Controls Cheat Sheet

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5 "Whys" for Root Cause Analysis Technique Cheat Sheet

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5 Tips for a Successful 510(k) Submission
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5 Tips for a Successful 510(k) Submission

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8 Quick Facts about CAPA Cheat Sheet
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8 Quick Facts about CAPA Cheat Sheet

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ISO 13485:2016: Changes You Should Know About
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ISO 13485:2016: Changes You Should Know About

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

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Failure Mode Effects Analysis (FMEA) Template
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Failure Mode Effects Analysis (FMEA) Template

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Medical Device Product Development Checklist
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Medical Device Product Development Checklist

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FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist
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FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

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Budgeting for MedTech Clinical Activities Checklist
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Budgeting for MedTech Clinical Activities Checklist

Securing the budget for clinical activities can be daunting, especially when you don't know where to start. Here's a checklist to break it down for you with key considerations on ...

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

Here are our pointers on what you should be aware of if you're looking to achieve compliance with FDA's 21 CFR Part 11, particularly when collecting or maintaining clinical data.

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Checklist for Clinical Data Collection and Efficient Study Setup
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Checklist for Clinical Data Collection and Efficient Study Setup

Preparing for clinical data collection is a very important step. This checklist will help you consider some of the most important items before setting up your clinical study.

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FDA 483/Warning Letter Response Template
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FDA 483/Warning Letter Response Template

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Risk Management Plan Template
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Risk Management Plan Template

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