Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device)
Dr. Oliver Eidel
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Clinical Evaluation
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Updated August 11, 2026
A requirement for when you develop software as a medical device (SaMD) is that you have to be compliant with the IEC 62366, which is a standard about Usability.
The long story short is that you have to do user testing and a few other things. And how do you do those things? Take a look at this video in which I give you an introduction.
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.
The long story short is that you have to do user testing and a few other things. And how do you do those things? Take a look at this video in which I give you an introduction.
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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