Hazard-Related Use Scenarios (Risk Analysis for Medical Devices + Usability Engineering)

Hazard-related use scenarios are a weird thing where two standards for medical device compliance overlap: The ISO 14971 (risk management) and the IEC 62366 (usability engineering). In short, you have to analyze which of the use scenarios of your device might lead to hazards. Luckily, documenting that is very easy if you're using the right software (guess which one I'm using).

So in this video, I'll walk you through documenting user needs and related hazards, resulting in hazard-related use scenarios.

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/