Point-by-point cybersecurity responses, scoped artifact updates, and testing evidence for manufacturer review.
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
275+ FDA submissions supported, zero cybersecurity rejections.
We review the hold letter, its deadline, and your existing evidence to define the technical response. The proposal identifies artifact updates, testing needs, manufacturer inputs, and dates. The FDA decides whether the response addresses its concerns.
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
The proposal identifies included deliverables, exclusions, manufacturer inputs, and review responsibilities for this engagement.
Senior reviewer reads your letter, maps every finding to required artifacts, and returns a written closure plan with effort estimate.
Every response is written against the February 2026 final premarket cybersecurity guidance and Section 524B(b)(1)-(3).
Updated cybersecurity evidence is organized with response and page references for your regulatory team to review and assemble. We do not promise that a hold will be lifted.
We identify the documentation and testing needed to address the letter, including dependencies on other evidence. The proposal records scope and exclusions.
Cover letter and redlines structured the way cybersecurity reviewers want: finding → response → evidence → page reference.
One quote covers the response and any follow-up exchanges with the FDA until the cybersecurity hold is lifted.
Hold letters cluster around a handful of recurring asks. Recognizing the pattern in yours shortens the response cycle.
Single-device STRIDE submissions are getting held for missing fleet-level harm analysis. Most common ask under the February 2026 final guidance.
Component list without affected/not-affected/fixed/under-investigation status for each listed CVE is the second most common hold trigger.
524B(b)(1) requires a written description of how patches reach fielded devices. Verbal process descriptions get held; controlled outputs don't.
Reviewers want to see each pen test finding traced back to a threat-model entry. Standalone pen test reports get held for traceability.
What you actually get versus a generic regulatory consultant or a re-spin in-house while the clock burns.
| Capability | Blue Goat Cyber | Generic regulatory consultant | In-house |
|---|---|---|---|
| Hold-letter response track record | Routine - written for the reviewer who sent it | Treats hold like any other AI letter | First time under hold pressure |
| Speed under deadline | Dates agreed after letter and evidence review | Hourly, drifts with scope | Competes with launch work |
| Point-by-point response mapping | Mirrors hold-letter exactly | General rewrite, items missed | Built from scratch under pressure |
| Evidence package | Updated SPDF + SBOM/VEX + threat model + pen test | Documentation only, no fresh testing | Multiple owners, integration gaps |
| Pricing model | Fixed fee, revisions included | Hourly + change orders | Hidden internal cost |
Discuss architecture, available records, access, responsibilities, and target dates. Agree confidential handling before transferring device material.
The proposal identifies included work, exclusions, manufacturer inputs, and delivery milestones. The 24-hour quote turnaround is separate from delivery, remediation, and review time.
Update the artifacts and testing identified by the letter review. Deliver a point-by-point response with evidence references for your regulatory team to review and submit. The FDA decides the outcome.
"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 question, we answer it at no extra cost until the cybersecurity portion is closed.
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
The quote identifies deliverables, assumptions, and dates. Quote turnaround is separate from the time needed to deliver the work.
Senior-led cybersecurity work within the agreed scope. Your team reviews the evidence and owns risk, release, and submission decisions.
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+ FDA submissions supported, zero cybersecurity rejections. 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 within 24 hours of the scoping call. Delivery and review dates are agreed separately.
