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.
Updated October 12, 2022
Getting Started
Dr. Oliver Eidel
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, just send me an email.