Whether the FDA called it a Deficiency Letter, an AINN (Additional Information Needed Notification), or an Additional Information Request - the cybersecurity findings are the same set of gaps we close every week. Senior US-based team, eSTAR-ready response, mutual NDA before the call, free 24-hour written strategy.
Trusted by medical device teams worldwide
Each FDA finding gets a numbered response with the exact artifact, page reference, and Section 524B citation that closes it.
Same playbook whether the FDA calls it an AINN, additional information request, or deficiency letter - we've responded to all of them.
Refreshed SPDX or CycloneDX SBOM with VEX statements addressing any CVE concerns the FDA raised.
We pen-test only what the FDA asked about - fastest path to closing the file, not padding the invoice.
Structured exactly the way FDA cybersecurity reviewers expect: finding → response → evidence → location in submission.
One quote covers the response and any follow-up exchanges until the cybersecurity file is closed. No retest invoices.
We've responded to hundreds of FDA cybersecurity deficiency letters. The findings cluster into the same handful of categories - these are the ones we close every week.
Reviewer asks for a machine-readable SBOM (SPDX or CycloneDX) with VEX statements addressing every flagged CVE. We rebuild it to FDA expectations.
STRIDE-based threat model missing data-flow diagrams, trust boundaries, or mitigations traced to design controls. We refresh it end-to-end.
Reviewer wants vulnerability testing, fuzz testing, or penetration testing scoped to the device's actual interfaces. We run a targeted retest, not a full re-scope.
Missing traceability between Section 524B(b)(1)–(3) requirements and submission artifacts. We deliver a refreshed matrix the reviewer can check off.
Secure product development framework documentation that doesn't show evidence of execution. We pair the SPDF with artifacts that prove it ran.
Reviewer wants a credible coordinated vulnerability disclosure (CVD) process, SBOM monitoring plan, and patch cadence. We document what you'll actually do.
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. Mutual NDA signed before the call. Free written response strategy mapped to every FDA finding within 24 hours. Fixed-fee quote to close the file.
