A cybersecurity hold stops your 510(k), De Novo, or PMA review until the FDA gets satisfactory answers. We've taken 250+ FDA submissions through cybersecurity review with zero rejections - and we move on hold letters in days, not months. Free 24-hour review of your letter.
Free 30-min call · Senior US expert · Mutual NDA before the call
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 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 | Reviewer-ready package in 2-4 weeks | 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, unlimited revisions until accepted | Hourly + change orders | Hidden internal cost |
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 Cyber helped us navigate our first end-to-end cybersecurity testing for our wearable medical device. Their communication was excellent, their timeline exceeded expectations, and their report helped us achieve FDA clearance without any additional questions. It was a truly seamless experience."
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.
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 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.
