A common pitfall in medical device development is confusing FMEA (Failure Mode and Effects Analysis) with an ISO 14971 Risk Analysis. While an FMEA is a valuable bottom-up reliability tool analyzing how components fail, ISO 14971 requires a top-down analysis of how the device impacts the patient.
Notified Bodies frequently issue non-conformities when an FMEA is presented as the sole Risk Management File. An FMEA often misses use-errors, clinical hazards, and systemic software failures.
MedMI is built from the ground up for ISO 14971. We guide your team to focus on hazardous situations and foreseeable sequences of events that lead to patient harm, ensuring your documentation meets the actual standard, not just an engineering reliability metric.
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