Articles

Updated August 3, 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, Safety Officer, 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 slightly different note: Did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?

And there's so much more: If you're looking for the best QMS software ever, look no further. We've built Formwork, and it's free!

If you're interested in watching me write documentation for a medical device, check out our screencasts. And finally, there's our free Slack community with 500+ people from medical device companies in which people help each other out by answering questions. You should check it out! :)

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)

If you're still lost and have further questions, just send me an email. Read more about me here.

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