IEC 62304 - Compliant Software Development Process (SOP Software Development)
Dr. Oliver Eidel
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IEC 62304: Medical Device Software Development
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Updated November 26, 2025
00:00 Extremely boring introduction
01:00 I am a terrible teacher
03:03 The template
06:49 Creating it in Formwork
08:20 How to fill it out
If you're developing software as a medical device, for IEC 62304 compliance, you have to document your software development process (among other things). I'll walk you through an example documentation for that - we call it the SOP Integrated Software Development and it's as fancy as it sounds.
Check out our website https://openregulatory.com for more!
The software I'm using in the video is Formwork, our eQMS software. Check it out here: https://openregulatory.com/
01:00 I am a terrible teacher
03:03 The template
06:49 Creating it in Formwork
08:20 How to fill it out
If you're developing software as a medical device, for IEC 62304 compliance, you have to document your software development process (among other things). I'll walk you through an example documentation for that - we call it the SOP Integrated Software Development and it's as fancy as it sounds.
Check out our website https://openregulatory.com for more!
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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