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. 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
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.
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. eSTAR-ready report, unlimited retests included.
