510(k) cybersecurity submission services aligned to the FDA February 2026 final premarket cybersecurity guidance.
Every document the FDA expects in your 510(k) cybersecurity section - SPDF, SBOM with VEX, threat model, penetration test report, and Section 524B attestation - delivered eSTAR-ready by a senior US-based team. 250+ FDA submissions, zero cybersecurity rejections.
Not sure which package fits? Compare in 10 seconds:
510(k) submission
Predicate-based clearance. Cybersecurity section sized to a 510(k) eSTAR.
Premarket, any pathway
Full cyber package for 510(k), De Novo, or PMA. Start here if pathway is TBD.
PMA & De Novo
Higher-risk. Multi-patient harm view + fielded postmarket program at filing.
Section 524B compliance
Cyber device? SPDF + SBOM + postmarket + CVD proven to the 524B statute.
Free 30-min call · Senior US expert · Mutual NDA before the call
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“Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. Their expertise and smooth process mean we can focus on our product, not the paperwork.”
Amy Lynn, Chief Compliance Officer, Medivis
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
Built to the February 2026 final premarket cybersecurity guidance and Section 524B(b)(1)-(3). Reviewer-ready format, not raw findings.
Cybersecurity content drops directly into eSTAR - no reformatting, no missing attachments, no acceptance-checklist surprises.
Machine-readable SPDX or CycloneDX SBOM, NTIA minimum elements (now stewarded by CISA), plus VEX statements for every CVE in your shipping configuration.
End-to-end system 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 mapped to your threat model with remediation tracking.
Fixed fee. Retests are included until risks are mitigated and the cybersecurity section is reviewer-ready. No per-retest invoices.
Every one of these has shown up in a real FDA 510(k) deficiency letter or acceptance-checklist hold. We close them before you submit.
Component supplier, version, and known-unknowns fields incomplete or missing. Reviewer cannot evaluate vulnerability exposure - automatic deficiency.
STRIDE entries exist but no mapping to security controls, test evidence, or residual risk. Reviewer asks for the full SW96 / TIR57 traceability matrix.
Only the device firmware was tested; cloud, mobile companion, and wireless interfaces were skipped. Reviewer requires the full attack surface.
Premarket package missing a monitoring + coordinated vulnerability disclosure plan. Required for every cyber device since March 2023.
No customer security guide, no SBOM disclosure, no end-of-support communication. Reviewer cites missing transparency under 524B(b)(2).
Global, multi-patient harm, and updateability views missing or inconsistent with the threat model. Reviewer cannot evaluate reasonable assurance.
What you actually get versus a generic 510(k) shop or assembling the cyber attachment in-house.
| Capability | Blue Goat Cyber | Generic 510(k) shop | In-house |
|---|---|---|---|
| Cybersecurity-specific 510(k) experience | Dedicated cyber team, not regulatory generalists | Regulatory writers without cyber depth | Engineering owns it on top of dev work |
| eSTAR-attachable deliverables | Formatted for the cybersecurity attachment | Word docs that need reformatting | Built once, reformatted each time |
| Threat model + SBOM + VEX + pen test | All four, one integrated package | Subcontracted across vendors | Multiple owners, integration gaps |
| Cyber-deficiency rate on submissions | Zero across 250+ | Variable, often triggers AI letters | First-submission risk |
| Pricing model | Fixed fee, unlimited revisions until accepted | Hourly + change orders | Hidden internal cost |
We sign a mutual NDA, then walk your 510(k) architecture, predicate device, 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.
SPDF, SBOM with VEX, threat model, pen test report, and cybersecurity labeling - delivered in eSTAR-attachable format ready to submit.
"Blue Goat Cyber takes the burden off our engineers and makes FDA cybersecurity requirements easy to understand. Their expertise and smooth process mean we can focus on our product, not the paperwork. The organized documentation, perfectly formatted for eSTAR, saves us countless hours."
If the FDA raises a cybersecurity deficiency, we fix it at no additional cost. 250+ FDA submissions, zero cybersecurity 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.
Senior-led delivery on every FDA-facing artifact. No offshoring, 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, zero cybersecurity rejections. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30 minutes with a senior medical device cybersecurity engineer. Mutual NDA signed before the call. No pitch - we'll tell you straight if you don't need us.
