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Uncategorized November 22, 2022 · 1 min read · Last updated October 01, 2024

IEC 62366

Dr. Oliver Eidel
Dr. Oliver Eidel
OpenRegulatory

The IEC 62366 is about usability of medical device software. In practice, it’s mostly about running usability tests with users. This page is a collection of all our articles on this usability standard. We also publish all our document templates for the IEC 62366 for free and you can find them below!

IEC 62366 Templates

We’ve published all our IEC 62366 templates for free, no strings attached! Take a look :)

Questions Other Companies Ask Us About IEC 62366

All IEC 62366 Articles

Dr. Oliver Eidel

Dr. Oliver Eidel

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!
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All articles
A

Do You Need Video Cameras For User Testing?

Anonymous
about 2 years ago
We’re currently planning our IEC 62366 - compliant Summative Usability Evaluation, which means that we’ll be doing usability testing with our software. We’ve got a group of test users and have prepare
Accepted 1 answer

No, you don’t need video and screen recordings. Long Answer There are no hard requirements for user testing. At minimum, you need some sort of proof

Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device) 5:42

Getting Started With The IEC 62366 (Usability Engineering For Software as a Medical Device)

Dr. Oliver Eidel

331 views · almost 3 years ago
A

What's the Minimum Number of Users for a Usability Test?

Anonymous
about 2 years ago
We’re planning our usability testing, i.e. our IEC 62366 - compliant Summative Usability Evaluation. Is there any sort of minimum number of users we need to include?
Accepted 1 answer

At minimum, between five and fifteen. Long Answer If you just got started by reading some regulation, your disillusioned self will assume that someth

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