Continuously monitor your medical device SBOMs for new vulnerabilities, prioritize what actually matters, and produce audit-ready evidence for FDA postmarket cybersecurity - without the noise.
Built by the team behind 250+ FDA submissions. Zero rejections.
Trusted by leading MedTech companies
A pip-freeze or `npm ls` is not an SBOM. Reviewers expect a layered, build-derived inventory that covers every layer ships in the device and is paired with per-CVE VEX statements. Every layer below is in scope by default.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Every fda-compliant sbom services engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every fda-compliant sbom services engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
Statutory requirement that every cyber device 510(k), De Novo, PMA, and IDE submission include a complete cybersecurity package or face Refuse to Accept (RTA).
End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.
International standard for security activities across the health software product lifecycle.
International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
The single advisory that made SBOM/VEX a regulatory expectation rather than a best practice. Manufacturers without an accurate component inventory could not answer 'is your device affected' on the FDA's timeline.
A widely embedded library shipped in nearly every connected medical device. Demonstrated again that a current SBOM plus a VEX feed is the only way to triage exposure within a regulatory response window.
Stack-level vulnerabilities affected over 200 device families. Underscored that SBOMs must reach below the application layer down to embedded TCP/IP stacks and RTOS components.
"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. Their quick communication and ability to set clear expectations made all the difference."
Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
View Full-Service FDA Premarket CybersecurityBake cybersecurity into your device from day one.
View Secure MedTech Product DesignEnd-to-end FDA premarket cybersecurity package for Software as a Medical Device - cloud, mobile, and web SaMD.
View SaMD CybersecuritySee how this service applies to your specific MedTech segment.
Curated reading for teams working on sbom - grouped by format so you can jump to what you need.
Long-form reference reading - architecture, frameworks, and end-to-end how-tos.
Shorter posts on the specific gotchas, deficiencies, and reviewer expectations we see most.
Pressure-test the work yourself before you scope an engagement. No signup, results are yours to keep.
"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."
Continuously monitor your medical device SBOMs for new vulnerabilities, prioritize what actually matters, and produce audit-ready evidence for FDA postmarket cybersecurity - without the noise.
