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July 24, 2022


Dr. Oliver Eidel

The OpenRegulatory Blog. If you’ve scrolled down this far, you’re probably bored with all the other regulatory articles above and are just searching for entertainment. Maybe our blog can help you there?

All Blog Articles

How MDD Devices Die: Two Case Studies From The Real World
We're Making Medical Device Compliance 10x Cheaper
Wise Business Is Great, Unless You Need Access To Your Money: Our Experience
List of Controversial Auditor Opinions
Do We Need a Call?
We Got Audited By a Competent Authority. Here's What You Need To Know.
We're Sending Out Honest Rejections Now
DiGAs and the Telekom Cloud Run On Chinese Software From Huawei. Say What?
Before Our Call: Frequently Asked Questions
Four Problems For DiGA Companies In The Future
We're Launching Free Consulting
The Great Notified Body Survey
No Cookie (Consent Dialogue) For You
Don't Hire Senior Regulatory Affairs People

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.