Articles Technical Documentation
Updated December 2, 2022
Dr. Oliver Eidel
ISO 14971 is the standard for risk management of medical device software. This page is a collection of all our articles on risk management. We also publish all our document templates for the ISO 14971 for free and you can find them below!
We’ve published all our ISO 14971 templates for free, no strings attached! Take a look :)
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!
Get notified when we post something new.
Sign up for our free newsletter.
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.