Updated August 3, 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 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: Declaration of Conformity for MDD Class I Devices
Template: Checklist: MDR General Safety and Performance Requirements

All General Documents Articles

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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