Every article in our archive tagged SBOM.
Showing 12 of 12 articles tagged SBOM
The FDA PCCP guidance isn't AI-only. Use a predetermined change control plan for cybersecurity patches, firmware updates, and SBOM component swaps.
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How to wire SAST, SBOM, secrets, container, and signature gates into a medical-device CI/CD pipeline so the SPDF produces the evidence FDA reviewers.
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A subsection-by-subsection walkthrough of FDA Section 524B for cyber medical devices: what §524B(a), (b)(1), (b)(2), (b)(3), (b)(4), and (c) require.
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What the CISA Known Exploited Vulnerabilities (KEV) catalog is, how medical device manufacturers should use it in SBOM/VEX triage, and how the FDA treats.
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How Health Canada regulates medical device cybersecurity in 2026: pre-market license expectations, MDEL obligations, and how to reuse an FDA Section 524B.
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How the TGA regulates medical device cybersecurity in Australia in 2026: ARTG entry expectations, the TGA cybersecurity guidance, and how to reuse FDA.
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Where containers appear in medical devices, the testing the FDA expects under the Feb 3, 2026 guidance, and how container evidence maps to eSTAR v7.0.
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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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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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The concrete SBOM elements FDA reviewers verify at RTA screening: format, identifiers, vulnerability disposition, and update process, based on 250+ reviews.
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How MedTech teams should identify, triage, and document VxWorks RTOS vulnerabilities (URGENT/11 and beyond) for FDA Section 524B premarket and postmarket.
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SBOM + SAST explained: how component transparency and static code scanning strengthen medical device cybersecurity and align with FDA guidance.
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