Bottom-Up vs Top-Down
Engineers love FMEAs (Failure Mode and Effects Analysis), but regulatory auditors often reject them when presented as the sole Risk Management document.
Component Failure vs Patient Harm
An FMEA is a reliability tool. It looks at a component (e.g., a resistor) and asks, "What happens if this fails?" This is a bottom-up approach.
Regulatory Expectations
ISO 14971 requires a top-down approach. It asks, "What hazards are present in the clinical environment, and how could they lead to patient harm?"
While an FMEA is an excellent tool for verifying risk controls (specifically reliability), it completely misses usability errors, software logic flaws, and biological hazards. A compliant technical file uses ISO 14971 as the master document, with FMEAs supporting specific engineering mitigations.