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Tag: IEC 62366

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!

Articles

Technical Documentation

How To Do a Summative Usability Testing For IEC 62366 Compliance

Updated over 1 year ago

Dr. Oliver Eidel

Technical Documentation

The IEC 62366 (Usability) Summary: All You Need To Know (It's Not Much)

Updated over 1 year ago

Dr. Oliver Eidel

Technical Documentation

How To Do Formative Usability Testing For Medical Devices

Updated over 1 year ago

Dr. Oliver Eidel

Questions

A

Formative vs. Summative Usability Testing - What's The Difference?

Anonymous
over 1 year ago
What's the difference between formative and summative usability testing?
Accepted 1 answer

For summative usability testing, you need to do a user test (5 users or more in the EU, 15 in the US). For formative usability testing, you can "what

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

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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