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 since 2014
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, and PMA 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.
Full-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
Learn moreBake cybersecurity into your device from day one.
Learn moreCode-level vulnerability discovery to support FDA expectations.
Learn moreSee how this service applies to your specific MedTech segment.
"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.
