Every article in our archive in Risk Management.
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 in Risk Management
Benefit-risk analysis weighs medical device benefits against residual risks. Learn how ISO 14971, FDA pathways, and cybersecurity evidence fit together.
Read article
Medical device cybersecurity should scale with device risk. Christian Espinosa argues why meeting only the Section 524B minimum leaves patients and submissions exposed.
Read article
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.
Read article
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.
Read article
FMEA covers random and systematic failure modes; threat modeling covers adversarial action.
Read article30-minute strategy session. No cost, no commitment - just answers from people who've supported 275+ FDA submissions, with zero cybersecurity rejections.
