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 3 of 3 articles in SBOM & Supply Chain
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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EOS vs EOL vs Level of Support in your medical device SBOM: what Section 524B requires, how to express it in CycloneDX and SPDX, and how to defend it.
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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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