Don't know where to start? Watch our free starter videos and save lots of time and consultant fees

Articles Questions

July 23, 2020

Do You Need Video Cameras For User Testing?

Dr. Oliver Eidel


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 prepared a protocol which lists the steps they need to perform. Now we’re wondering what the requirements for documentation of this user test are - do we need video recordings? Screen recordings? That would make things more difficult. We want to get it right the first time and minimize the risk of having to re-do user tests.

Short 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 that you did it, which steps were performed and any usability problems you encountered (and whether you solved them). The minimum viable implementation of this would be a simple protocol per user test which includes the steps performed, whether they were performed successfully and which problems were encountered.

Video and/or screen recordings are nice to have for your internal purposes but not a must from a regulatory perspective.

Don’t forget to have a sufficiently large number of users (at least five).

Good luck! :)

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

Congratulations! You read this far.

Get notified when we post something new.

Sign up for our free newsletter.

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!


If you have any questions or would like to share your opinion publicly, feel free to comment below. If you'd like to reach out privately, send us a message.

No QMS on this planet will save you from creating crappy software.