Medical device cybersecurity services, premarket packages, pen testing, SBOM, threat modeling, and postmarket.
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
275+ devices supported · No cybersecurity-related rejections to date
A senior US-based team owns the whole cybersecurity side of your FDA submission. Everything is built to Section 524B and the FDA February 2026 final premarket guidance.
Free 30-min call · Senior US expert · Mutual NDA before the call
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“Blue Goat Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device.”
Anna Norman, VP of Product, InfoBionic.Ai
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
510(k), De Novo, and PMA cybersecurity sections delivered eSTAR-ready and mapped to Section 524B(b)(1) through (3).
Device, cloud, mobile, and wireless attack surfaces tested by senior engineers. Findings mapped to your threat model with remediation tracking.
End-to-end STRIDE threat model with multi-patient harm, updateability, and use-environment views. Aligned to ANSI/AAMI SW96, with AAMI TIR57 as the implementation guide.
Machine-readable SPDX or CycloneDX SBOM with NTIA minimum elements (now stewarded by CISA), support-end dates, and a VEX statement for every CVE in your shipping configuration.
Vulnerability monitoring sources, severity-based response timelines, coordinated vulnerability disclosure policy, and patch delivery aligned to 524B(b)(1).
Hold letters, refuse-to-accept, and AI cybersecurity deficiency letters. Point-by-point reviewer-ready responses in days, not weeks.
What you actually get versus a horizontal cyber firm or building a medical device cyber program in-house.
| Capability | Blue Goat Cyber | Horizontal cyber firm | In-house |
|---|---|---|---|
| Medical device cyber specialization | Medical devices only, premarket + postmarket | Enterprise IT shop adapting to devices | Hard to hire device-specific skills |
| Standards coverage | FDA + ANSI/AAMI SW96 + IEC 81001-5-1 + TIR57 + TIR97 + ISO 14971 | Generic NIST/ISO 27001 | Built clause-by-clause |
| Threat model + SBOM + VEX + pen test | One integrated team, all four | Pen test only, no submission artifacts | Multiple owners, integration gaps |
| Submission track record | 275+ devices supported | Limited or no FDA experience | First-submission risk |
| Pricing model | Fixed-fee program, predictable | Hourly retainers + change orders | Unbudgeted FTE time |
We sign a mutual NDA, then a senior medical device cybersecurity engineer walks your device, submission stage, and the cybersecurity evidence the FDA reviewer will expect.
Point-by-point gap list against Section 524B and the FDA February 2026 final guidance, each gap mapped to the artifact that closes it, with a fixed-fee quote covering every deliverable.
Secure Product Development Framework (SPDF), SBOM with VEX, threat model, pen test, postmarket plan, and cybersecurity labeling. Delivered reviewer-format with revisions included.
"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 raises a cybersecurity deficiency, we fix it at no additional cost. 275+ devices supported.
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. Revisions included. 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 275+ devices supported. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30-minute call with a senior medical device cybersecurity expert. Mutual NDA signed before the call. Fixed-fee quote within 24 hours of the call.
