Preparing the Usability Evaluation Protocol for IEC 62366 (Medical Device Compliance)
Dr. Oliver Eidel
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Clinical Evaluation
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Updated August 11, 2026
We need to prepare before we get into the most important part, the User Test for our Summative Evaluation.
We need a list of tasks with instructions and acceptance criteria before heading into our user test!
We'll learn:
- How to "convert" the List of Hazard-Related Use Scenarios to tests in the Usability Evaluation Protocol.
- How to avoid the most common problem: Writing Software System Tests.
- How to come up with useful instructions and acceptance criteria.
- How many tests to have for each Hazard-Related Use Scenario.
And finally, here's the link to our template:
https://openregulatory.com/usability-evaluation-protocol-template-iec-62366/
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.
We need a list of tasks with instructions and acceptance criteria before heading into our user test!
We'll learn:
- How to "convert" the List of Hazard-Related Use Scenarios to tests in the Usability Evaluation Protocol.
- How to avoid the most common problem: Writing Software System Tests.
- How to come up with useful instructions and acceptance criteria.
- How many tests to have for each Hazard-Related Use Scenario.
And finally, here's the link to our template:
https://openregulatory.com/usability-evaluation-protocol-template-iec-62366/
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.
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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