Struggling to meet the FDA's cybersecurity testing requirements? We identify vulnerabilities and deliver FDA-ready reports - fast, accurate, and aligned with current guidance. We recommend white-box testing for medical devices, and so does the FDA.
250+ Devices Secured. Zero FDA Rejections.
Trusted by leading MedTech companies
Generic penetration testing firms lack the understanding of unique device architecture, patient risks, and regulatory demands. Their reports may be thorough, but not FDA-compliant - and they almost always default to black-box only.
The FDA expects testers to leverage source code, threat models, and architecture (white-box). Black-box-only engagements miss the deep flaws reviewers ask about - and lead to deficiencies.
Generic vendors miss firmware, wireless, and embedded paths unique to medical devices.
Reports without FDA-aligned structure, traceability, and evidence get rejected by reviewers.
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 | Gray-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.
"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."
The full stack a connected medical device exposes - from the clinician portal down to the implant firmware. Every layer is in scope when it matters to patient safety or regulatory submission.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
Every medical device penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every medical device 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.
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.
Reference methodology for planning, executing, and reporting security testing.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about - and what this engagement is built to cover.
Conexus RF protocol lacked encryption and authentication, allowing nearby attackers to read or modify implant communications. Drove industry-wide expectations on telemetry confidentiality and integrity.
Multiple advisories spanning auth bypass, hard-coded credentials, and improper input validation. Reinforced reviewer scrutiny of in-hospital network-exposed devices.
Improper auth between monitor and cloud allowed certain monitor functions to be impersonated. Demonstrates why home-monitor + cloud must be tested together, not separately.
Wi-Fi credential persistence and improper access control. Drove the FDA's continued focus on credential lifecycle and decommissioning in hospital-deployed devices.
Secure your Wi-Fi and wireless attack surface.
View Wireless Penetration TestingFull-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
View Full-Service FDA Premarket CybersecurityGot an FDA hold or AI letter? We close cybersecurity deficiencies fast.
View FDA Deficiency ResponseSee how this service applies to your specific MedTech segment.
Curated reading for teams working on medical device penetration testing - grouped by format so you can jump to what you need.
Long-form reference reading - architecture, frameworks, and end-to-end how-tos.
Shorter posts on the specific gotchas, deficiencies, and reviewer expectations we see most.
Pressure-test the work yourself before you scope an engagement. No signup, results are yours to keep.
Struggling to meet the FDA's cybersecurity testing requirements? We identify vulnerabilities and deliver FDA-ready reports - fast, accurate, and aligned with current guidance. We recommend white-box testing for medical devices, and so does the FDA.
