Updated August 3, 2022

ISO 14971 Templates

Dr. Oliver Eidel

ISO 14971 is the standard for risk management of medical device software.

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 slightly different note: 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!

If you're interested in watching me write documentation for a medical device, check out our screencasts. And finally, there's our free Slack community with 500+ people from medical device companies in which people help each other out by answering questions. You should check it out! :)

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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.

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