Just Launched: Halo for Change Management. Stop reacting. Start predicting. Introducing predictive quality.
Learn more →
SOFTWARE
HALO
Halo
Halo for Change Management
Visualize
WHY GG
Why True Quality
Why Switch
Why Not Paper
State of Medical Device 2021
15 Questions to Ask QMS Vendors
5 Do's and Don'ts of QMS Software
Ultimate Guide to Comparing QMS Solutions
RESOURCES
eBooks & Guides
Events
Checklists & Templates
Webinars
Podcasts
Glossary
Thought Leadership Articles
Press
Blog
FAQ
Join Newsletter
PARTNER
CUSTOMERS
Case Studies
Testimonials
BLOG
See the Demo
FREE DOWNLOADS
TIPS, CHECKLISTS, AND TEMPLATES FROM SEASONED MEDICAL DEVICE PROFESSIONALS AVAILABLE AT YOUR FINGERTIPS
More than 68,000 rely on us for the latest in quality
Change Impact Analysis Template
Download the Resource
Download the Resource
Change Order Template
Download the Resource
Download the Resource
Nonconformance Report Template
Download the Resource
Download the Resource
Free Replay Package: 2021 Medical Device Virtual Summit
Download the Resource
Download the Resource
Checklist: 7 Steps to Comply with FDA 21 CFR Part 11
Download the Resource
Download the Resource
Value of True Quality Infographic
Download the Resource
Download the Resource
Training Matrix Template
Download the Resource
Download the Resource
Top 100 Medical Device Startups with Most Money Raised in 2020 Chart
Download the Resource
Download the Resource
Biocompatibility Testing Selection Criteria
Download the Resource
Download the Resource
Human Factors & Usability Engineering Report
Download the Resource
Download the Resource
Complaint Template
Download the Resource
Download the Resource
Nonconformance Template
Download the Resource
Download the Resource
CAPA Template
Download the Resource
Download the Resource
7 Steps for Writing a Nonconformance Report
Download the Resource
Download the Resource
3 Tips for Receiving EUA from FDA
Download the Resource
Download the Resource
10 Ways A Modern, Cloud-Based MDQMS Helps Remote Teams Stay Ahead
Download the Resource
Download the Resource
IVDR Gap Assessment Tool
Download the Resource
Download the Resource
MDD vs. MDR Gap Assessment Tool
Download the Resource
Download the Resource
5 Myths about PMA's (and what's actually true)
Download the Resource
Download the Resource
Content Toolkit for Medical Device Executive Leaders
Download the Resource
Download the Resource
Content Toolkit for Medical Device QA/RA Professionals
Download the Resource
Download the Resource
Content Toolkit for Medical Device Product Developers
Download the Resource
Download the Resource
Quality Culture Flowchart
Download the Resource
Download the Resource
EU MDR: SaMD Guidance Document + Audit Gap Assessment Tool
Download the Resource
Download the Resource
21 CFR Part 820 Resource Pocket Guide for Avoiding Most Common Mistakes
Download the Resource
Download the Resource
Product Requirements Guide + Checklist with Writing Tips
Download the Resource
Download the Resource
MDSAP vs. ISO 13485:2016 Gap Assessment Tool
Download the Resource
Download the Resource
EU MDR Gap Analysis Tool
Download the Resource
Download the Resource
Suggested Quality Domain Metrics
Download the Resource
Download the Resource
Compliance or Quality Focused Comparison Chart
Download the Resource
Download the Resource
What Influences SaMD Classification?
Download the Resource
Download the Resource
Benefits of a Formal Document Management Solution
Download the Resource
Download the Resource
5 FDA 510(k) Submission Mistakes to Avoid
Download the Resource
Download the Resource
What Medical Device Investors Want to See Checklist
Download the Resource
Download the Resource
FDA Program Comparison Table
Download the Resource
Download the Resource
4 Cornerstones of an Effective eQMS
Download the Resource
Download the Resource
6 Ways AI is Transforming Healthcare
Download the Resource
Download the Resource
Top 100 Medical Device Companies in the World Chart
Download the Resource
Download the Resource
5 Practical R&D Tips for Medical Device Developers
Download the Resource
Download the Resource
Key Questions for Defining User Needs
Download the Resource
Download the Resource
7 Tips for Incorporating Human Factors into Device Design
Download the Resource
Download the Resource
Tips to Building Consistent QMS Procedures
Download the Resource
Download the Resource
5 Tips for a Competitive Regulatory Strategy
Download the Resource
Download the Resource
5 Tips for Better DHF Management Cheat Sheet
Download the Resource
Download the Resource
Most Common Sources of Post-market Surveillance Data
Download the Resource
Download the Resource
15 Steps to Create a Risk-based CAPA Process Infographic
Download the Resource
Download the Resource
Ultimate List of Medical Device Incubators & Accelerators
Download the Resource
Download the Resource
4 Steps to Gathering Accurate Complaint Data
Download the Resource
Download the Resource
Overview of a Customer Complaint-handling Procedure
Download the Resource
Download the Resource
Guide to When to Use Different Tools for CAPA Analysis
Download the Resource
Download the Resource
FDA 483 & Warning Letter Checklist
Download the Resource
Download the Resource
510(k) Submission Checklist
Download the Resource
Download the Resource
Cheat Sheet on Preparing Your Team for an FDA Inspection
Download the Resource
Download the Resource
7 Signs You're Ready for an eQMS
Download the Resource
Download the Resource
5 Ways to Prepare Your Team for an FDA Inspection
Download the Resource
Download the Resource
6 Survey Tools for Gathering User Needs
Download the Resource
Download the Resource
Using Your 510(k) Submission for Design Controls and DHF Table
Download the Resource
Download the Resource
5 Tips for Using a Predicate Device
Download the Resource
Download the Resource
4 Signs You Need to Issue a CAPA
Download the Resource
Download the Resource
Key Elements of Your Design History File Checklist
Download the Resource
Download the Resource
10 Resources to Get Medical Device Companies on Track
Download the Resource
Download the Resource
5 Key Steps for Getting Your Medical Device CE Mark
Download the Resource
Download the Resource
Sample Management Review Template
Download the Resource
Download the Resource
Tips to Help Define User Needs
Download the Resource
Download the Resource
4 Helpful Tips for Better Management of Your Design History File
Download the Resource
Download the Resource
9 Tips for Password Compliance with 21 CFR Part 11
Download the Resource
Download the Resource
4 Reasons the Root Cause Isn't "User Error" Cheatsheet
Download the Resource
Download the Resource
What FDA Expects to See as Part of Your CAPA Process Cheatsheet
Download the Resource
Download the Resource
5 Step Checklist to Determine If a CAPA Is Required
Download the Resource
Download the Resource
Checklist for Selecting Suppliers to Your Medical Device Company
Download the Resource
Download the Resource
4 Methods for Root Cause Analysis Cheat Sheet
Download the Resource
Download the Resource
7 Rules for Effective Medical Device Design Controls Cheat Sheet
Download the Resource
Download the Resource
5 "Whys" for Root Cause Analysis Technique Cheat Sheet
Download the Resource
Download the Resource
5 Tips for a Successful 510(k) Submission
Download the Resource
Download the Resource
8 Quick Facts about CAPA Cheat Sheet
Download the Resource
Download the Resource
ISO 13485:2016: Changes You Should Know About
Download the Resource
Download the Resource
ISO 13485:2016 vs FDA 21 CFR Part 820 Full Comparison Table
Download the Resource
Download the Resource
Failure Mode Effects Analysis (FMEA) Template
Download the Resource
Download the Resource
Medical Device Product Development Checklist
Download the Resource
Download the Resource
FDA QSR & ISO 13485: 2016 Internal QMS Audit Checklist
Download the Resource
Download the Resource
FDA 483/Warning Letter Response Template
Download the Resource
Download the Resource
Risk Management Plan Template
Download the Resource
Download the Resource
5 Tips to Help your FDA 510(k) Submission
Download the Resource
Download the Resource