We manage 100% of your FDA cybersecurity submission - SPDF, SBOMs, threat modeling, penetration testing, and all documentation - for 510(k), PMA, and De Novo clearances.
250+ Submissions. Zero Rejections.
Trusted by leading MedTech companies since 2014
Every full-service fda premarket cybersecurity engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every full-service fda premarket cybersecurity 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).
FDA's mandatory interactive submission template with structured upload slots for each cybersecurity artifact.
End-to-end secure development lifecycle the FDA expects to see referenced and evidenced in every cyber device submission.
The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.
Got an FDA hold or AI letter? We close cybersecurity deficiencies fast.
Learn moreContinuous compliance, monitoring, and vulnerability response.
Learn moreCreate, validate, and maintain SBOMs for premarket and postmarket.
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."
We manage 100% of your FDA cybersecurity submission - SPDF, SBOMs, threat modeling, penetration testing, and all documentation - for 510(k), PMA, and De Novo clearances.
