SBOM
Software Bill of Materials · software bill of materials · cbom
A formal, machine-readable inventory of every software component (libraries, OS, firmware) shipped in a product — now required by FDA premarket cybersecurity guidance.
An SBOM lists every software component, including transitive dependencies, in a release — typically in SPDX or CycloneDX. FDA's 2023 premarket cybersecurity guidance and EU MDR/IVDR cybersecurity expectations require manufacturers to provide and maintain SBOMs so vulnerabilities (CVEs) can be tracked across the device's lifetime.
V5 attaches an SBOM to each software release record and continuously matches it against CVE feeds to surface relevant vulnerabilities into post-market risk review.
- FDA Premarket Cybersecurity Guidance (2023)
- EU MDR Annex I §17
Free trial, no credit card, onboard in days, not months.