Full-scope medical device penetration testing for FDA premarket submissions - device firmware, cloud backends, mobile companion apps, wireless and BLE/RF - delivered as a reviewer-ready report mapped to your threat model and Section 524B. 250+ FDA submissions supported, zero cybersecurity rejections.
Free 30-min call · Senior US expert · Mutual NDA before the call
Trusted by medical device teams worldwide
As featured in
Device, cloud, mobile, and wireless tested independently - not a single web-app scan dressed up as a 'medical device pen test'.
Scoped to satisfy medical device penetration testing requirements under Section 524B(b)(2) and the February 2026 final premarket guidance.
Real RF gear, real protocol analyzers - not just nmap output. Connected device traffic, pairing flows, and OTA channels are all in scope.
Every finding is traced back to a STRIDE threat and a Section 524B(b) clause - reviewers can follow finding → threat → mitigation → evidence.
Executive summary, methodology, scope, findings with CVSS, remediation, and retest evidence - formatted the way FDA cybersecurity reviewers expect.
One quote covers initial test plus retests until every finding is closed. No per-retest invoices, no hourly billing.
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 Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience."
If the FDA rejects your submission for cybersecurity reasons, we fix it at no additional cost. 250+ submissions, zero cyber 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.
No offshoring, no junior hand-offs, 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 with a 100% cybersecurity success rate. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30-minute call with a senior medical device cybersecurity expert. Free written scope and fixed-fee quote within 24 hours. Reviewer-ready report, unlimited retests included.
