PMA and De Novo cybersecurity submission services aligned to the FDA February 2026 final guidance.
Higher-risk submissions need deeper cybersecurity evidence - multi-patient harm views, complete pen-test scope, and a fielded postmarket cybersecurity management plan. We own all of it for PMA and De Novo, aligned to Section 524B and the FDA February 2026 final guidance. 250+ submissions, zero cyber 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's niche expertise in FDA-facing cybersecurity made all the difference. Their reports were built with the FDA's expectations in mind-it gave us confidence that we were submitting exactly…”
Scott Odland, Solutions Architect, Rhaeos
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
Threat model includes a multi-patient harm analysis required for higher-risk devices - not just the single-patient view sufficient for many 510(k)s.
Device, cloud, mobile, wireless, BLE/RF, and any clinical workflow integrations. Independent testers, documented scope, and reviewer-ready findings.
Secure Product Development Framework integrated with QMSR (21 CFR 820), ISO 13485 design controls, and your ECO/change management process.
Vulnerability monitoring, CVD procedures, patch authentication, rollback, and Section 524B(b)(1) postmarket reporting - operational before market.
If a Major Deficiency Letter or hold lands, we author the point-by-point response, cover letter, and traceability matrix inside your 180-day clock.
We help you frame the cybersecurity questions for a Pre-Submission meeting so reviewer expectations are locked in before you file.
Higher-risk pathways get deeper FDA review. These are the cybersecurity gaps that trigger Major Deficiency Letters on PMA and De Novo submissions.
Threat model considers harm to one patient but not the multi-patient cascade - the failure mode FDA expects to see addressed on PMA-class devices.
Device-only pen test with no cloud API or wireless coverage. Reviewers flag the missing attack surface and the submission stalls.
SPDF exists as a standalone document with no traceability into design controls, ECOs, or risk management. Reviewers ask for the integration evidence.
Postmarket cybersecurity management plan describes what you intend to do, not what is operational. Reviewers want evidence the program exists today.
Device connects to clinical networks or shared infrastructure with no documented compensating controls for the connected environment.
ISO 14971 risk file does not include cybersecurity-driven hazards or controls. Mandatory under AAMI TIR57 alignment and called out by reviewers.
What you actually get versus a PMA consultant without cyber depth, or building Class III cyber evidence in-house.
| Capability | Blue Goat Cyber | PMA consultant without cyber depth | In-house |
|---|---|---|---|
| Class III / De Novo cyber experience | Submissions across Class II + III + De Novo | Cyber treated as add-on to regulatory work | Built clause-by-clause from statute |
| SPDF + threat model + SBOM + VEX | Integrated, reviewer-format | Piecemeal across subcontractors | Multiple owners, integration gaps |
| Postmarket commitments documented | CVD + monitoring + patch SLAs | Premarket only | Deferred until audit |
| Submission track record | 250+, zero cyber rejections | Variable, cyber-specific track unclear | First-submission risk |
| Pricing model | Fixed fee, unlimited revisions until accepted | Hourly + change orders | Hidden internal cost |
Mutual NDA, then a 30-minute call to map your device classification, intended use, multi-patient exposure, and the cybersecurity evidence the reviewer will expect.
Point-by-point cybersecurity strategy mapped to Section 524B and the FDA February 2026 final guidance, plus a fixed-fee quote covering threat model, pen test, SPDF, and postmarket plan.
Multi-patient threat model, full-scope pen test, SPDF integrated into your QMS, and postmarket cybersecurity management plan - delivered in eSTAR-attachable format.
"Blue Goat's niche expertise in FDA-facing cybersecurity made all the difference. Their reports were built with the FDA's expectations in mind-it gave us confidence that we were submitting exactly what reviewers want to see."
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.
