Postmarket SBOM Monitoring & VEX Automation
Operational postmarket cybersecurity for cleared medical devices: continuous SBOM diffing against NVD/CISA-KEV/OSV, automated VEX triage, CVE-to-patient-harm risk scoring, and CAPA-ready evidence packs - aligned with FDA postmarket guidance, ANSI/AAMI SW96, and ISO 14971 risk management.
250+ FDA submissions. Zero rejections.
- Senior team
- Fixed-fee
- Reviewer-ready
- Re-test included
- Free 30-min call
- No obligation
- Senior expert, not a sales rep
- Fixed-fee quote in 24 hours
- NDA available on request
Trusted by leading MedTech companies
What continuous SBOM + VEX monitoring covers
Postmarket SBOM monitoring is more than re-running a generator. The pipeline produces a fresh inventory per release, correlates it against current CVE feeds, produces VEX statements for each affected component, and feeds the postmarket plan SLAs.
- 01Build-time SBOM generator (CycloneDX 1.5 / SPDX 2.3)
- 02Release-to-release SBOM diff
- 03CVE feeds (NVD, OSV.dev, GHSA, vendor advisories)
- 04KEV + EPSS enrichment
- 05VEX statement authoring + publication (CSAF 2.0)
- 06Triage workflow + reviewer queue
- 07Customer notification path
- 08QMS evidence pack
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Reviewer-ready deliverables in one engagement
Every postmarket sbom monitoring & vex automation engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
- Continuous SBOM ingestion (SPDX 2.3 / CycloneDX 1.5+) and diff-on-build
- Automated VEX (Vulnerability Exploitability eXchange) statements per CVE
- CVE-to-patient-harm risk scoring traced into ISO 14971 risk file
- CISA-KEV, NVD, OSV, GitHub Advisory feed monitoring
- CAPA-ready evidence packs with auditor-grade traceability
- FDA postmarket cybersecurity report draft for material changes
Public postmarket cybersecurity history
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
-
curl maintainers + NVD·2023
curl CVE-2023-38545 SBOM stress test
A single library disclosure that touched essentially every connected device. Teams without continuous SBOM + VEX could not answer 'are we affected' inside the FDA's expected response window.
Advisory -
GitHub + Sonatype·2022-2024
PyPI / npm typosquatting supply-chain incidents
Ongoing supply-chain incidents make package-provenance and version pinning a postmarket-monitoring concern, not just a build-time one. The pipeline must flag dependency drift between releases.
Postmarket SBOM Monitoring & VEX Automation FAQs
Backed by MedTech leaders.
"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
Postmarket SBOM Monitoring & VEX Automation - scoped, fixed-fee, FDA-ready.
Operational postmarket cybersecurity for cleared medical devices: continuous SBOM diffing against NVD/CISA-KEV/OSV, automated VEX triage, CVE-to-patient-harm risk scoring, and CAPA-ready evidence packs - aligned with FDA postmarket guidance, ANSI/AAMI SW96, and ISO 14971 risk management.