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Updated October 12, 2022

Case Studies

Dr. Oliver Eidel

Case studies of companies going through the medical device compliance process.

These include case studies of our clients which typically get their software certified for very little money in very little time, and case studies of startups working with other consultants which spend a ton of money and never get done.

All Case Studies Articles

FBE GmbH: Solving Problems and Reviewing Documents For Less Than 2.000€
Exakt Health: MDD Class I Compliant in 3 Months
100.000€ Spent and Never Done (Fail)

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.