Medical Device Usability Engineering: Writing User Tests (Summative Evaluation of IEC 62366)
Dr. Oliver Eidel
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IEC 62366: Medical Device Usability Engineering
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Updated November 26, 2025
In the second video of our free medical device usability engineering course, we'll be creating some user tests. Those fulfill the requirement of conducting a "summative evaluation" as per the IEC 62366, which is the usability engineering standard for medical devices.
00:00 Introduction & recap
02:20 Creating our first user test
10:07 Creating our second user test
10:50 Google Sheets would be hell
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our here:
https://openregulatory.com/
00:00 Introduction & recap
02:20 Creating our first user test
10:07 Creating our second user test
10:50 Google Sheets would be hell
The software I'm using in the video is Formwork, our eQMS software. It's the most affordable eQMS software and perfect for startups. Check it our 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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