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Articles tagged with “sbom”

IEC 81001-5-1 Implementation: An Evidence Crosswalk

A 2026 implementation guide mapping IEC 81001-5-1 activities to owners and evidence, with December 2025 corrections, IEC 62304 overlap, FDA submission mapping and lifecycle coverage calculations.

23 min read

10/13/2026

iec 81001-5-1 implementation iec 81001-5-1 medical device cybersecurity secure software development lifecycle iec 62304 fda cybersecurity guidance threat modeling sbom cybersecurity evidence

AI Medical Device Cybersecurity: Regulations & Risks

Learn cybersecurity requirements for AI medical devices. Covers FDA guidance, EU regulations, SBOM mandates, and defenses against adversarial AI attacks.

60 min read

2/6/2026

ai medical devices medical device cybersecurity iomt security fda guidance adversarial machine learning sbom eu ai act risk management saamd