Every article in our archive in SBOM & Supply Chain.
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 4 of 4 articles in SBOM & Supply Chain
VEX resources for medical device teams: a document guide, SBOM comparison, and common assessment mistakes, with evidence-based status and regulatory context.
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SBOM for SaMD and cloud components: what FDA guidance recommends for cloud services, containers, and third-party APIs, and how to keep the SBOM current after release.
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When a chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware in the device.
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SBOM vs VEX explained for medical device submissions. What each document does, how they pair, and what the FDA actually expects in your 510(k) package.
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