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
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
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.