Every article in our archive tagged ISO 14971.
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 5 of 5 articles tagged ISO 14971
Benefit-risk analysis weighs medical device benefits against residual risks. Learn how ISO 14971, FDA pathways, and cybersecurity evidence fit together.
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Does the FDA care about stolen PHI from a medical device? How confidentiality fits security risk, when it reaches ISO 14971 harm, and what HIPAA covers.
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Cybersecurity hazard analysis for medical devices: how to turn confidentiality, integrity, and availability losses into hazards, harms, and risk controls in your ISO 14971 file.
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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 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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