Creating a Simple Risk Table for ISO 14971 (Risk Management For Medical Devices)

Let's get started with something straightforward: Thinking about what could possibly go wrong.

We'll be creating a simple risk table which will (hopefully) end up being a full-blown Failure Mode and Effects Analysis (FMEA):
- How to define failure modes (in a simple way).
- Thinking about the medical impact (what will happen in the end?).
- Very roughly estimating probability and severity.

Check out the Wikipedia article on FMEA with a pretty good explanation and examples:
https://en.wikipedia.org/wiki/Failure_mode_and_effects_analysis

And here's our FMEA template - we don't need this now, but in a later video when our FMEA table is more complete :)
https://openregulatory.com/fmea-risk-table-template-iso-14971/

This video is part of our free medical device compliance library. Browse all videos on our website, watch them on the OpenRegulatory YouTube channel, or follow the courses inside Formwork.