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.
The short answer
Section 524B requires a software bill of materials for every cyber device. The FDA expects a machine-readable SBOM, usually CycloneDX or SPDX, covering commercial, open-source and off-the-shelf components, with each component's support status and end-of-support date and an assessment of known vulnerabilities. We build the SBOM from your source and binaries, validate it, add VEX statements and set it up to stay current after clearance.
Built by the team behind 275+ devices supported. no cybersecurity-related rejections to date.
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.
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."
See 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.
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.
