We close every cybersecurity gap on the FDA Refuse to Accept (RTA) checklist and rebuild your eSTAR cyber section so you can resubmit in weeks.
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
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 30-min discovery call.
Free 30-min call · Senior US expert · Mutual NDA before the call
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“The timeliness of this project exceeded my expectations; this was not my experience with other vendors.”
Tim Sandberg, Vice President of IT Operations, Matrix One
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
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 (now stewarded by CISA), 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.
The RTA letter usually names a checklist line. The underlying root cause is almost always one of these - and we close all six in the rebuild.
The attestation block isn't present, or it's there but the supporting evidence sections are empty. Acceptance reviewer flags it on the first pass.
Submission shipped without an SBOM, or with a non-machine-readable PDF instead of SPDX/CycloneDX. Auto-checklist fail.
A threat model exists internally but never made it into the eSTAR cybersecurity attachments. Reviewer can't accept what isn't there.
Pen test report covers only firmware while the device clearly has cloud and mobile interfaces. Reviewer rejects on incomplete scope.
Secure Product Development Framework written for internal use, not attached as a controlled output in the submission. Easy RTA trigger.
No customer security guide, no SBOM disclosure, no end-of-support communication. Reviewer cites missing transparency under 524B(b)(2).
What you actually get versus a generic regulatory consultant or scrambling to fix the cyber RTA findings in-house.
| Capability | Blue Goat Cyber | Generic regulatory consultant | In-house |
|---|---|---|---|
| RTA cybersecurity-checklist coverage | Every cyber RTA item, mapped and closed | Regulatory focus, cyber items left thin | First time mapping the checklist |
| Speed to resubmission | Reviewer-ready package in 2-4 weeks | Hourly, drifts with scope | Competes with engineering work |
| eSTAR-attachable deliverables | Drop-in for resubmission | Word docs that need reformatting | Reformatted each time |
| Track record | 275+ devices supported | Variable, cyber-specific track unclear | First-submission risk |
| Pricing model | Fixed fee, revisions included | Hourly + change orders | Hidden internal cost |
We sign a mutual NDA, then walk your RTA letter, checklist gaps, and any prior cybersecurity work to scope the rebuild.
Point-by-point rebuild plan mapped to every checklist gap in your RTA letter, each gap tied to the artifact that closes it, with a fixed-fee quote to resubmit.
Full cybersecurity section rebuilt: SPDF, SBOM with VEX, threat model, pen test, and Section 524B attestation - dropped straight into eSTAR.
"The timeliness of this project exceeded my expectations; this was not my experience with other vendors. Blue Goat Cyber delivered a thorough, detailed report and complete testing faster than I anticipated, without compromising quality."
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. Fixed-fee quote to resubmit within 24 hours of the call.
