Great video. I can’t Believe no one has commented yet. PS been on RU-vid from the beginning and you’re the first person I’ve ever commented. Keep up the good work.
In their 2016 Usability Guidance the FDA says that Human Factors Engineering represents one portion of design validation. Then the QSR doesn't mention usability at all in 820.30, how would you incorporate that into design controls?
Although the QSR does not include human factors or usability, the QMSR that goes into effect on February 26, 2026 will incorporate ISO 13485:2016 by reference. In Clause 7.3.3 (i.e., Design Inputs), the IEC 63266-1 standard is referenced. Therefore, companies are expected to establish use specifications and user interface specifications as part of the design process and these specifications would be verified and validated. In other countries, the requirements to include usability are specifically indicated as an essential principle of safety and performance.
Those are good suggestions for our "What is []?" playlist. We already have one video on the FMEA: ru-vid.com/video/%D0%B2%D0%B8%D0%B4%D0%B5%D0%BE-ct6OyCKRAQk.html, but a couple of short videos where we display examples would be helpful. I'll also add a few of the other risk analysis tools, such as a FTA.
Now that I have added the timestamps, if you are not a history buff you can skip to the next time stamp where I talk about the need to modernize the QSR.
