Software Architecture For Medical Device Software (IEC 62304 Compliance)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Introduction
01:14 Example: German Covid App
02:45 A better approach
08:04 Stay pragmatic
09:10 Swagger documentation
When developing software as a medical device, the IEC 62304 also requires you to document your software architecture. In most cases, this boils down to creating a document which is somewhat clunky. I'll walk you through the clunky document in this video.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:14 Example: German Covid App
02:45 A better approach
08:04 Stay pragmatic
09:10 Swagger documentation
When developing software as a medical device, the IEC 62304 also requires you to document your software architecture. In most cases, this boils down to creating a document which is somewhat clunky. I'll walk you through the clunky document in this video.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
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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!
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!
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