An RTA on cybersecurity grounds means your 510(k) never made it past the FDA acceptance checklist - usually a missing SPDF, SBOM, threat model, or Section 524B attestation. We rebuild the cybersecurity section eSTAR-ready and get you resubmitted fast. Free 24-hour RTA review.
Trusted by medical device teams worldwide
Every cybersecurity item on the FDA acceptance checklist is present, labeled, and formatted exactly as reviewers expect in eSTAR.
Built to the February 2026 final premarket cybersecurity guidance and Section 524B(b)(1)–(3) - no second RTA on cyber grounds.
Machine-readable SPDX or CycloneDX SBOM, NTIA minimum elements, plus VEX statements addressing every CVE in shipping software.
End-to-end threat model with multi-patient harm, updateability, and use-environment views. Aligned to AAMI TIR57 / ANSI/AAMI SW96.
Device, cloud, mobile, and wireless attack surfaces tested independently. Findings traced back to threat model and risk file.
One quote covers rebuild, retest, and any follow-up exchanges until the cybersecurity section is accepted.
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 closed every cybersecurity finding on our 510(k) in a single response round. Senior engineers, fixed fee, no surprises - exactly what we needed against the clock."
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 personally scopes every engagement. 250+ FDA medical device submissions supported 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 rebuild plan mapped to every RTA checklist gap within 24 hours. Fixed-fee quote to resubmit.
