Full postmarket cybersecurity program built to the FDA Postmarket Management of Cybersecurity in Medical Devices guidance and Section 524B(b)(1) - coordinated vulnerability disclosure (CVD), SBOM monitoring, threat intel, patch management, and FDA reporting. 250+ FDA submissions supported, zero cybersecurity rejections.
Free 30-min call · Senior US expert · Mutual NDA before the call
Trusted by medical device teams worldwide
Built to FDA Postmarket Management of Cybersecurity in Medical Devices guidance and Section 524B(b)(1) - controlled, uncontrolled risk, and compensating controls all covered.
Public CVD policy, intake workflow, triage SLA, and disclosure timelines - modeled on ISO/IEC 29147 and 30111, accepted by FDA reviewers.
Your shipping SBOM monitored against NVD/CISA feeds. New CVEs triaged, VEX statements regenerated, and customer comms drafted on a fixed cadence.
Decision framework for emergency patches, planned updates, and end-of-support - every decision documented and audit-ready.
When a vulnerability triggers an FDA report (uncontrolled risk, MDR-eligible event), the workflow, template, and timeline are already in place.
Monthly retainer or annual fixed fee. No per-CVE invoicing. Every quarter you get a written postmarket program review.
When we audit an existing postmarket cybersecurity program, these are the gaps that show up first - and the ones FDA inspectors notice.
No security@ address, no published disclosure policy, no triage SLA. Researchers either go public or go away - both are bad outcomes.
An SBOM was generated for the submission and never looked at again. New CVEs against shipped components are not being detected, scored, or VEX'd.
When a vulnerability crosses the uncontrolled-risk threshold, there is no documented path to an FDA postmarket report - so it does not get filed.
Software updates ship without signature verification on the device side, or without rollback. A 524B(b)(1) finding waiting to happen.
Devices past their supported life are still in clinical use, with no documented compensating controls or sunset communication to customers.
Every CVE triggers a fresh internal debate about what to tell customers. No template, no cadence, no audit trail of what was disclosed when.
What you actually get versus a reactive MDR vendor or running postmarket monitoring on a spreadsheet.
| Capability | Blue Goat Cyber | Reactive MDR vendor | In-house |
|---|---|---|---|
| Built to FDA postmarket guidance + 524B(b)(1) | Mapped to every clause, reviewer-ready | Generic SOC/MDR playbook | Built from scratch, often incomplete |
| Coordinated Vulnerability Disclosure (CVD) program | Policy, intake, triage, comms - operated for you | Not offered | Hard to staff, easy to neglect |
| SBOM + VEX kept current per release | Continuous, with per-CVE VEX statements | Static SBOM at handoff | Ages quickly without governance |
| Pricing model | Fixed-fee program, no per-CVE invoicing | Per-alert / per-incident billing | Unbudgeted internal time |
| Quarterly reviewer-format evidence | Included, audit-ready | Tickets only, no narrative | Pulled together at audit time |
Mutual NDA, then a 30-minute call to map your devices in-market, existing postmarket controls, SBOM coverage, and any open CVEs or customer disclosures.
CVD policy published, security@ intake live, SBOM-to-feed monitoring wired up, and the patch/update decision framework documented inside your QMS.
New CVEs triaged within SLA, VEX statements regenerated, customer comms drafted, and FDA postmarket reports filed when thresholds are met. Quarterly written program review.
"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 postmarket gap review within 24 hours. Fixed-fee program quote, no per-CVE billing.
