Risk Management· Jun 25, 2026
Design FMEA for Medical Devices: dFMEA
How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand cyber failure modes to the threat model.
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Looking for a quick answer instead? The FDA medical device cybersecurity FAQ covers Section 524B scope, SBOMs, threat models, CR515 and GMLP, deficiencies, and postmarket duties.
Showing 2 of 2 articles tagged FMEA
How to run a design FMEA (dFMEA) for a connected medical device, link it to the ISO 14971 risk file, and hand cyber failure modes to the threat model.
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FMEA covers random and systematic failure modes; threat modeling covers adversarial action.
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