Hiring or looking for a job in Digital Health? Check out our Digital Health Jobs board


July 23, 2022


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 Articles

What Is Clinical Evidence (MDR)?
How To Find Out Whether Your Regulatory Consultant Sucks
What Is a Clinical Development Plan?
How To Analyze And Report "Trends" Under The MDR?
How Do We Certify API-Only Software As a Medical Device?
What Is "FDA 21 CFR Part 820" Compliant eQMS Software?
What is IFA?
What is a GS1? Shedding light on the UDI provider
What is a MDR UDI? Unraveling the Importance of Unique Device Identification
What's the Difference Between a Document and a Record?
How Can We Set Up a QMS in Sharepoint?
Should We Choose Our Cloud Provider Based on Free Credits?
Can We Bring a Lifestyle Device to Market First?
Do We Need AI / Machine Learning Consultants?
Should You Do a BfArM Classification Request? The Answer Is No.
QMS Software And Jira / GitHub / GitLab Integrations: Don't Make a Mistake!
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 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.

Congratulations! You read this far.

Get notified when we post something new.

Sign up for our free newsletter.

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.