A documented, repeatable testing methodology aligned with the FDA's 2026 premarket guidance, ANSI/AAMI SW96, ISO 14971, IEC 62443-4-1, and NIST 800-115 - designed to minimize risk to live systems and produce evidence that maps cleanly into your ISO 13485 quality records.
250+ FDA submissions. Zero rejections.
Trusted by leading MedTech companies since 2014
For medical devices, both Blue Goat and the FDA recommend white-box testing. Reviewers expect testers to leverage source, firmware, and threat models - black-box alone routinely leads to deficiencies.
| Capability | Black-box | Grey-box | White-box |
|---|---|---|---|
| Source code access | |||
| Firmware / binaries | |||
| Threat model & architecture | |||
| Authenticated test paths | |||
| Deep logic + business-flow flaws | |||
| Aligned with FDA expectations | |||
| Scope coverage per test-day |
Premarket guidance and consensus standards both expect testers to leverage source code, design artifacts, and threat models, not just an external view of the device.
Calls for security testing that demonstrates device resilience using design documentation, threat models, and source-level analysis, not black-box probing alone.
Requires sponsors to provide reasonable assurance that the device and related systems are cybersecure - which reviewers read as evidence-backed, white-box-informed testing.
Frames security testing as an output of threat modeling and architecture analysis. That is white-box by definition.
Postmarket monitoring and vulnerability handling assume testers have access to internals - the same access white-box pen testing uses premarket.
Every pen testing methodology engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every pen testing methodology 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.
Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.
Reference methodology for planning, executing, and reporting security testing.
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
FDA-compliant device, firmware, app, and cloud testing.
Learn more10+ years testing medical devices for 510(k) and PMA clearance.
Learn moreBlack, gray, and white box testing for compliance and real-world defense.
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."
A documented, repeatable testing methodology aligned with the FDA's 2026 premarket guidance, ANSI/AAMI SW96, ISO 14971, IEC 62443-4-1, and NIST 800-115 - designed to minimize risk to live systems and produce evidence that maps cleanly into your ISO 13485 quality records.
