FDA-grade medical device penetration testing - device, cloud, mobile, and wireless attack surface, reviewer-format report.
Penetration testing built specifically for FDA premarket submissions under Section 524B and the February 2026 final premarket cybersecurity guidance. Device, cloud, mobile, and wireless tested - report formatted the way FDA cybersecurity reviewers expect.
Free 30-min call · Senior US expert · Mutual NDA before the call
Last updated
“Blue Goat provided testing on our system for cybersecurity and provided the necessary documentation to add to our regulatory submission.”
Bernie Lane, Engineer Manager, CSA Medical Inc
The FDA Test Report requirement asks for an explicit independence statement. Reviewers check for it before they read findings. Every Blue Goat Cyber report includes it, named oversight included.
Our pen test team has no role in writing your device firmware, cloud code, or mobile app, and never has. No remediation work, no architecture authorship, no source contributions. The independence statement in your report names the team and the boundary.
Inside Blue Goat Cyber, the pen test team is structurally separate from any consulting or remediation work we do for you. Oversight sits with our CTO and our VP of Regulatory Affairs, both named in the report so reviewers can trace accountability.
3 to 4 retest rounds is typical. Some submissions take 20+. One fixed fee covers them all. We do not bill per retest, per finding, or per round.
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
Scoped, executed, and reported against the February 2026 final premarket cybersecurity guidance and Section 524B(b)(1)-(3).
Report structure drops directly into eSTAR - no reformatting, no missing attachments, no acceptance-checklist surprises.
Device firmware, cloud APIs, mobile apps, Wi-Fi, BLE, and RF - tested independently and reported with separate findings sections.
Each finding traces back to a STRIDE threat and a Section 524B(b) clause so reviewers can follow finding → threat → mitigation → evidence.
CVSS scoring, exploit details, concrete remediation steps, and retest evidence - formatted the way FDA cybersecurity reviewers expect.
One quote covers initial test plus retests until every finding is closed and the cybersecurity section is reviewer-ready.
Across 250+ FDA pen tests, the same classes of finding repeat. Most are fixable in a sprint - the cost is shipping a report without them flagged.
Mobile companion apps and clinician portals pass user JWTs that can read any device's telemetry. Multi-tenant isolation fails on the first IDOR probe.
Engineering left Just Works enabled for bench testing and the production firmware shipped with it. Trivially MITM-able from across the room.
Update package is signed, but the bootloader skips verification when a debug flag is set - and the debug flag ships enabled. Classic 524B(b)(1) finding.
Strings-grep finds MQTT broker creds, S3 access keys, or vendor portal tokens compiled into the binary. Same key across the entire fleet.
What you actually get versus a generic pen test shop or doing it in-house against a regulatory clock.
| Capability | Blue Goat Cyber | Generic pen test shop | In-house |
|---|---|---|---|
| Senior medical device cybersecurity engineers | Every project, US-based | Junior pen testers, rotating | Hard to hire and retain |
| FDA reviewer-format reports | eSTAR-attachable, 524B-mapped | Raw findings dump | Built from scratch each time |
| Unlimited retests until closed | Included, fixed fee | Billed per retest | Internal cycle cost |
| FDA submission track record | 250+, zero cyber rejections | Rare medical device experience | First submission risk |
| Mutual NDA before first call | Standard | Usually after SOW | n/a |
We sign a mutual NDA before the initial call, then walk through your submission, the FDA findings, and the path to close them.
You receive a point-by-point response strategy mapped to Section 524B and the FDA February 2026 final guidance, plus a fixed-fee quote.
Updated SPDF, SBOM/VEX, threat model, targeted pen test, and cover letter - formatted the way FDA cybersecurity reviewers expect in eSTAR.
"Blue Goat provided testing on our system for cybersecurity and provided the necessary documentation to add to our regulatory submission. They were very knowledgeable in the requirements, and performed the testing onsite which made the logistics of equipment availability easier for us. The communication was excellent, and they were able to expedite the testing and provide final reports in a very short period of time."
If the FDA raises a cybersecurity deficiency, we fix it at no additional cost. 250+ FDA submissions, zero cybersecurity rejections to date.
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
No sales pressure. After the call, you get a concrete written strategy mapped to Section 524B and the FDA February 2026 final guidance.
Senior-led delivery on every FDA-facing artifact. No offshoring, no hourly billing. Unlimited revisions. Every artifact is eSTAR-ready.
Who you're talking to
MBA, CISSP · U.S. Air Force Academy graduate · 30+ years in cybersecurity
Christian leads the senior medical device cybersecurity team behind 250+ FDA submissions, zero cybersecurity rejections. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30-minute call with a senior medical device cybersecurity expert. Fixed-fee scope and quote within 24 hours of the call. eSTAR-ready report, unlimited retests included.
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