Quality· Oct 20, 2024
21 CFR Part 820 and Medical Device Cybersecurity
21 CFR Part 820 explained: the 2026 QMSR shift to ISO 13485, what changed, and how design controls, CAPA, and Section 524B evidence connect.
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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.
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Standards· Jan 19, 2024
Conducting a Medical Device Security Audit
Step-by-step guide for medical device manufacturers to run a cybersecurity audit: scope, threat modeling, SBOM review, testing, and FDA-aligned documentation.
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