Technical Guide to Information Security Testing
Reference methodology for planning, executing, and reporting security testing.
External and internal network penetration testing to measure exposure, validate controls, and prioritize hardening.
250+ FDA submissions. Zero rejections.
Trusted by leading MedTech companies since 2014
















Every network penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every network penetration testing 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.
Reference methodology for planning, executing, and reporting security testing.
Govern, Identify, Protect, Detect, Respond, Recover - the lingua franca for cybersecurity program maturity.
Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.
Our 7-phase methodology built for FDA-regulated medical devices.
Learn moreFDA-compliant device, firmware, app, and cloud testing.
Learn more10+ years testing medical devices for 510(k) and PMA clearance.
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."
External and internal network penetration testing to measure exposure, validate controls, and prioritize hardening.