A cybersecurity hold stops your 510(k), De Novo, or PMA review until the FDA gets satisfactory answers. We've taken 250+ submissions through cybersecurity review with zero rejections - and we move on hold letters in days, not months. Free 24-hour review of your letter.
Trusted by medical device teams worldwide
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 content drops directly into eSTAR - no reformatting, no missing attachments, no second hold.
We pen-test, threat-model, and update only what the FDA asked about - fastest path to lifting the hold.
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.
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. Free written response strategy mapped to every FDA finding within 24 hours. Fixed-fee quote to lift the hold.
