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How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand off cyber-triggered failure modes to the threat model the FDA expects.
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FMEA covers random and systematic failure modes; threat modeling covers adversarial action. Both are required for a §524B submission, and they do not substitute for each other. Here is how to scope them, link them, and avoid the gap.
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