I'm not going to write you a crash course in medical device quality systems, but I'll mention the Failure Mode and Effects Analysis (FMEA). FMEAs are a core co

I'm not going to write you a crash course in medical device quality systems, but I'll mention the Failure Mode and Effects Analysis (FMEA). FMEAs are a core component of any risk management plan. In an FMEA, Failure Modes (what can go wrong) are identified and linked to Hazards and potential Harms that could result from the Failure Mode. The separate documentation that identified Hazards and Harms will have a Severity for each Harm. The FMEA will use that Severity and an engineering assessment of Occurrence probability for the Failure Mode to calculate risk. Mitigations (product requirements that reduce the likelihood of harm) are added until the occurrence is reduced to the point that residual risk is acceptable. Further reading: ISO 13485 (quality system) ISO 14971 (risk management) IEC 60812 (FMEA)