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Complaint Template

Nonconformance Template

CAPA Template

7 Steps for Writing a Nonconformance Report

3 Tips for Receiving EUA from FDA

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

IVDR Gap Assessment Tool

MDD vs. MDR Gap Assessment Tool

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

Content Toolkit for Medical Device Executive Leaders

Content Toolkit for Medical Device QA/RA Professionals

Content Toolkit for Medical Device Product Developers

Quality Culture Flowchart

EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool

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

Product Requirements Guide + Checklist with Writing Tips

MDSAP vs. ISO 13485:2016 Gap Assessment Tool

EU MDR Gap Analysis Tool

Suggested Quality Domain Metrics

Compliance or Quality Focused Comparison Chart

What Influences SaMD Classification?

Benefits of a Formal Document Management Solution

5 FDA 510(k) Submission Mistakes to Avoid

What Medical Device Investors Want to See Checklist

FDA Program Comparison Table

4 Cornerstones of an Effective eQMS

6 Ways AI is Transforming Healthcare

Top 100 Medical Device Companies in the World Chart

5 Practical R&D Tips for Medical Device Developers

Key Questions for Defining User Needs

7 Tips for Incorporating Human Factors into Device Design

Tips to Building Consistent QMS Procedures

5 Tips for a Competitive Regulatory Strategy

5 Tips for Better DHF Management Cheat Sheet

Most Common Sources of Post-market Surveillance Data

15 Steps to Create a Risk-based CAPA Process Infographic

Ultimate List of Medical Device Incubators & Accelerators

4 Steps to Gathering Accurate Complaint Data

Overview of a Customer Complaint-handling Procedure

Guide to When to Use Different Tools for CAPA Analysis

FDA 483 & Warning Letter Checklist

510(k) Submission Checklist

Cheat Sheet on Preparing Your Team for an FDA Inspection

7 Signs You're Ready for an eQMS

5 Ways to Prepare Your Team for an FDA Inspection

6 Survey Tools for Gathering User Needs

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

5 Tips for Using a Predicate Device

4 Signs You Need to Issue a CAPA

Key Elements of Your Design History File Checklist

10 Resources to Get Medical Device Companies on Track

5 Key Steps for Getting Your Medical Device CE Mark

Sample Management Review Template

Tips to Help Define User Needs

4 Helpful Tips for Better Management of Your Design History File

9 Tips for Password Compliance with 21 CFR Part 11

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

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

5 Step Checklist to Determine If a CAPA Is Required

Checklist for Selecting Suppliers to Your Medical Device Company

4 Methods for Root Cause Analysis Cheat Sheet

7 Rules for Effective Medical Device Design Controls Cheat Sheet

5 "Whys" for Root Cause Analysis Technique Cheat Sheet

5 Tips for a Successful 510(k) Submission

8 Quick Facts about CAPA Cheat Sheet

ISO 13485:2016: Changes You Should Know About

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

Failure Mode Effects Analysis (FMEA) Template

Medical Device Product Development Checklist

FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist

FDA 483/Warning Letter Response Template

Risk Management Plan Template

5 Tips to Help your FDA 510(k) Submission