Templates

Updated December 2, 2022

General Documents

Dr. Oliver Eidel

These include your intended use (super important) and your MDR classification document, among others. These are the most important ones so you should probably get started with those first.

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

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

All General Documents Templates

Template: MDR Declaration of Conformity
Template: MDR Classification Document
Template: MDD Classification Document
Template: Instructions for Use (IfU)
Template: MDD Essential Requirements
Template: Intended Use (for Medical Devices Under MDD / MDR)
Template: Checklist: MDR General Safety and Performance Requirements

All General Documents Articles

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.

Sign up for our free newsletter.

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.

Digital Health Jobs No Cookie For You Privacy Policy Imprint
No QMS on this planet will save you from creating crappy software.