Updated March 16, 2023

ISO 14971 Templates

ISO 14971 is the standard for risk management of medical device software. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the ISO 14971 so far. Additionally, we publish all our document templates for the ISO 14971 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)

The best news is that we’ve published all our ISO 14971 templates for free! Check them out below.

Also note that we have many more templates besides the ones for ISO 14971 - head over to our templates page for more templates.

All ISO 14971 Templates

Template: Risk Management Report

Template: Risk Management Plan and Risk Acceptance Matrix

Template: FMEA: Risk Table

All ISO 14971 Articles

FMEA, Part 1: Risk Acceptance Matrix (ISO 14971 Risk Analysis)

ISO 14971 Walkthrough

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided software which helps you create your documentation yourself, for only 149€ / month. No prior knowledge required. You should check it out.

Or, if you're looking for some human help, did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?

And there's so much more: If you're looking for the best QMS software ever, look no further. We've built Formwork, and it's free!

Congratulations! You read this far.

Get notified when we post something new.

Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)

If you're still lost and have further questions, just send me an email. Read more about me here.

Send me an email

Digital Health Jobs No Cookie For You Privacy Policy Imprint

No QMS on this planet will save you from creating crappy software.