Medical Device Software Development: Introduction To The IEC 62304
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 long PDF document and provides all sorts of (weird) requirements.
Let's take a look at the IEC 62304 and how you can develop your medical device software in compliance with it.
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.
Let's take a look at the IEC 62304 and how you can develop your medical device software in compliance with it.
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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