How Does The IEC 62304 V-Model Work For Software Development Of Medical Devices?
Dr. Oliver Eidel
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Clinical Evaluation
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Updated August 11, 2026
When you develop software as a medical device (SaMD), you have to develop and document it in a so-called IEC 62304 - compliant way. The IEC 62304 is a very lengthy PDF which, among other things, comes up with something called a "V-Model" for documenting software.
So, what the hell is this V-Model? How does it compare to waterfall and agile development?
This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
So, what the hell is this V-Model? How does it compare to waterfall and agile development?
This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.
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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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