Don't know where to start? Watch our free starter videos and save lots of time and consultant fees


Updated October 12, 2022

Getting Started

Dr. Oliver Eidel

If you have absolutely no clue about medical devices and where to start, this is the place to get your started! You’ll learn about coming up with the right classification for your medical device, writing your intended use, accessing standards for little money, and many other exciting things.

All Getting Started Articles

Medical Device Classification
The MDR Class I Software Situation
How to Classify Software as a Medical Device Under the MDR? (MDCG 2021-24)
MDD Class I: Here's What You Have to Do Before May 2021
People You Need: Person Responsible for Regulatory Compliance and Medical Device Consultants
Writing An Intended Use for Software as a Medical Device
Choosing a Notified Body
Start Here: The Blueprint for Certifying Medical Software
Accessing Standards For Less Than 30€

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.