SBOM for Third-Party Chip Firmware in Medical Devices
When the chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware, with the FDA-aligned evidence package.
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When the chip vendor's SBOM is enough, when it isn't, and what changes the moment a MedTech team modifies modem, radio, or SoC firmware, with the FDA-aligned evidence package.
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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 in.
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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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The 5 VEX document mistakes we see the FDA flag in cybersecurity deficiency letters - and exactly how to fix each one before you submit.
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