Articles

Updated August 3, 2022

Questions

Dr. Oliver Eidel

You might think your regulatory questions are unique to your situation, but chances are that other startups have already asked us. We publish all commonly-asked questions here.

All Questions Articles

How Can We Set Up a QMS in Confluence / Jira?
As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?
Do We Need a User Manual for Our Software as a Medical Device?
Should We Develop Our Software Or Set Up Our QMS First?
MDR Class 1 Devices: Do They Exist (as software)?
What's the Definition of a Medical Device According to the MDR?
Is Our Software a Medical Device (and Do We Need to Certify It)?
Do We Have to Read Those Boring Standards?
How Do SemVer Versions Map to Significant Changes for a Medical Device?
Software as a Medical Device: What's a Significant Change?
Machine Learning Software as a Medical Device: Can We Update Our Model?
Do We Have to Re-Do All Software System Tests After a Minor Change?
Can We Use GitHub and Other SaaS For Our Software as a Medical Device?
Should You Automate Your Software Architecture Documentation?
Do Auditors Read Your Code?
Do You Need Video Cameras For User Testing?
What's the Minimum Number of Users for a Usability Test?
Software Validation Procedure for ISO 13485 compliance?
How to document SOUP for IEC 62304 compliance?

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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