FDA Premarket Cybersecurity Guidance (Feb 3, 2026)
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
Wireless access points are often the easiest path into a network. We test corporate Wi-Fi, guest networks, and device-to-device wireless protocols.
250+ FDA submissions. Zero rejections.
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Every wireless penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every wireless 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.
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
Reference methodology for planning, executing, and reporting security testing.
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 more"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."
Wireless access points are often the easiest path into a network. We test corporate Wi-Fi, guest networks, and device-to-device wireless protocols.