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Updated July 26, 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: 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 video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

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