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March 23, 2023

Regulatory News

Dr. Oliver Eidel

Regulatory news and other exciting things happening in the regulatory world. Generally speaking, most updates here are about how your life is about to get more complicated and you’ll be writing even more documentation. But there are some much-appreciated exceptions!

All Regulatory News Articles

No, Telemedicine Software Is Not Class IIa Under The MDR
July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
Maybe Harmonized Standards Are Becoming Freely Available Soon
Brace for Impact: The New MDR Transition Periods

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.