Doing the Summative Usability Evaluation (User Tests Medical Device Compliance - IEC 62366)

The IEC 62366 requires us to do something called a "summative usability evaluation". For normal humans, this means conducting a user test. Let's look at how you could conduct a user test for a software medical device and document it in a way which contains all the relevant information which auditors expect to see.

00:00 Introduction & recap
01:32 IEC 62366 requirements (summative evaluation)
03:53 Executing user tests with humans
05:27 How cool is this
08:56 Doing another user test

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/