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.
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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.
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.
White-box is our default for premarket cyber devices - it's the only depth that gives FDA reviewers full coverage evidence. Gray-box adds credentialed ecosystem testing where it matters. Black-box is reserved for specific post-market or adversary-simulation scenarios.
Full source, firmware, and architecture access. The only depth that gives FDA reviewers full coverage evidence for cyber devices.
Learn morePartial credentials and architecture insight. A credentialed ecosystem add-on alongside white-box.
Learn moreZero prior knowledge. Reserved for adversary-simulation drills and specific post-market scenarios - not sufficient on its own for FDA.
Learn moreAligned to FDA Feb 2026 guidance, §524B, AAMI TIR57, ANSI/AAMI SW96, with CVSS v4.0 scoring.
Learn moreMost pen test firms ship a report. FDA reviewers are trained to look for something more specific - a signed Letter of Attestation in the format the premarket guidance describes. It's included in every Blue Goat engagement, no additional request required.
A signed document from the pen testing firm attesting that testing was conducted in accordance with FDA's premarket cybersecurity guidance, that the full attack surface was covered (firmware, hardware interfaces, wireless, mobile, APIs, cloud), and that every finding has been remediated or formally risk-accepted.
FDA's premarket cybersecurity guidance specifies that pen testing results should be documented in a format reviewers can audit. The Letter of Attestation is the standard format for that documentation - without it, the report often triggers a deficiency asking for one.
Generic IT security firms produce reports in their own format, not the format FDA reviewers are trained to evaluate. A Letter of Attestation in the correct format is included in every Blue Goat engagement - signed by the senior engineer who led the test, with no additional request required.
A transparent, side-by-side look at what you actually get - no vague promises.
Pre-submission penetration test required, with a tight 6-week window before FDA filing. Prior vendor returned a generic scan report that wouldn't satisfy 2026 guidance.
Complex multi-component system (implant, programmer, clinician portal) with PMA filing under FDA 2026 guidance. Needed full SBOM, threat model, and pen test evidence.
A sample of the kinds of issues we surface during medical device penetration tests. Devices and identifiers are redacted.
Allowed any nearby attacker to pair and exfiltrate ECG telemetry without user consent.
Remote attacker on hospital network could push unsigned firmware, altering dosing logic.
Patient identifiers and readings recoverable from a lost or stolen phone with no jailbreak.
Session prediction allowed cross-tenant access to clinician dashboards.
JTAG/UART left open allowed local code extraction and reverse engineering.
TLS 1.0 fallback exposed device-to-cloud channel to downgrade attacks.
Plug in your monthly burn, expected launch revenue, and delay window. Most manufacturers see $1M+ exposure on a single cyber hold. Most engagements are a small fraction of that.
Answer a few quick questions about your device classification, connectivity, and FDA path. We'll suggest the right testing track and surface the fastest wins for your submission.
Our team holds the offensive security certifications real attackers respect, backed by hands-on U.S. government red team and military cyber operations experience.
Our work has been honored by the leading voices in medical device cybersecurity.
Medical Tech Outlook
Cover story profiling Blue Goat Cyber as a top industry leader
MedTech World Malta 2025
Sponsored by the Malta Medicines Authority
Healthcare Business Review
Recognized for 250+ cleared FDA submissions and end-to-end medical device cybersecurity from premarket through postmarket
Our 7-phase methodology built for FDA-regulated medical devices.
Learn moreBlack, gray, and white box testing for compliance and real-world defense.
Learn moreFull-knowledge testing with administrator access and source code.
Learn moreSee 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.
"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."
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.
