Linking Up Failure Modes and Risk Controls (Medical Device Risk Analysis)

We've created failure modes and risk controls (awesome!), but we actually have to link them correctly in our documentation as otherwise our efforts were in vain (painful!). So that's what we're going to do. Failure modes need to be linked to hazards, and risk controls can be linked to software requirements, software tests, or user tests.

All of this is in line with what the ISO 14971 states for medical device risk management.

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/