Documenting SOUP (Software of Unknown Provenance) For IEC 62304 and Medical Device Compliance
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 SOUP documentation is useless
01:32 What does the IEC 62304 say?
02:59 How does the template look like?
05:13 How to do it in Formwork
08:39 How to fill out the columns
13:33 What do auditors look at?
As part of your medical device and IEC 62304 compliance, you have to document so-called Software of Unknown Provenance (SOUP). This activity doesn't make any rational sense. I'll walk you through it anyway.
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:32 What does the IEC 62304 say?
02:59 How does the template look like?
05:13 How to do it in Formwork
08:39 How to fill out the columns
13:33 What do auditors look at?
As part of your medical device and IEC 62304 compliance, you have to document so-called Software of Unknown Provenance (SOUP). This activity doesn't make any rational sense. I'll walk you through it anyway.
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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