Postmarket vulnerability management services for medical devices - SBOM monitoring, VEX, CVD, and FDA reporting.
If the FDA raises a cybersecurity question, we answer it at no extra cost until the cybersecurity portion is closed.
275+ devices supported · No cybersecurity-related rejections to date
Run a defensible postmarket vulnerability program for your in-market devices - CVD intake, SBOM monitoring, VEX updates, patch governance, and FDA reporting - built and operated by a senior US-based team.
Free 30-min call · Senior US expert · Mutual NDA before the call
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“Thoroughly enjoyed working with Blue Goat Cyber! Very knowledgeable and professional. Would work with again without hesitation!”
Eugene Yu, Director of Quality Assurance, RAQA Consultant
Trusted by medical device teams worldwide
Premarket to postmarket. One senior team owns every cybersecurity artifact the FDA reviewer will open.
Your shipping SBOM (SPDX or CycloneDX) matched daily in GoatWatch, our postmarket platform, against NVD, CISA KEV, and vendor advisories. New CVEs triaged within an SLA you set.
Every CVE gets a VEX statement - affected, not affected, fixed, under investigation - published in machine-readable format for customers and regulators.
Public disclosure policy, security@ intake, triage workflow, researcher comms, and CVE coordination - modeled on ISO/IEC 29147 and 30111.
Decision framework for emergency patches, planned updates, and end-of-support - every decision logged with rationale and risk justification.
When a vulnerability crosses the uncontrolled-risk or MDR-reportable threshold, the report workflow, template, and timeline are already in place.
Monthly retainer or annual fixed fee. Quarterly written program reviews. No surprise invoices when a busy CVE month hits.
Programs we onboard usually surface the same backlog of latent risk in the first month. Knowing what to expect shortens the catch-up window.
Most fleets we onboard have at least one component on CISA's Known Exploited Vulnerabilities catalog with no VEX status published. First triage closes the gap.
The SBOM submitted to the FDA doesn't match what's actually on devices in the field. Detected by comparing build manifests to a sampled device pull.
OpenSSL, BusyBox, or Linux kernel branches past vendor EOS but still in current builds. Triggers a 524B(b)(1) patch-delivery question whether the FDA asks or not.
Researchers can't reach you, so they go to the FDA or the press first. 30-minute fix that nobody had owned.
What you actually get versus an NVD-only scanner with a spreadsheet, or stitching it together internally.
| Capability | Blue Goat Cyber | NVD-only scanner + spreadsheet | In-house |
|---|---|---|---|
| Vulnerability sources | NVD + CISA KEV + vendor advisories + ICS-CERT | NVD feed only, no KEV prioritization | Whatever someone remembers to check |
| SBOM-driven triage | Per-component VEX statements per release | CVE list with no exploitability context | Manual lookups per CVE |
| Patch governance | Risk-ranked, owner-assigned, SLAs tracked | Email blasts, no follow-through | Ad-hoc, often missed |
| Reviewer-ready evidence | Quarterly narrative + audit log | Raw scanner exports | Built before each audit |
| Pricing model | Fixed-fee program, predictable | Per-CVE or per-alert invoicing | Unbudgeted FTE time |
Mutual NDA, then a 30-minute call to map your devices in-market, current postmarket controls, SBOM coverage, and any open CVEs or customer disclosures.
CVD policy published, security@ intake live, your SBOM loaded into GoatWatch with NVD/KEV/vendor feeds 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.
"Thoroughly enjoyed working with Blue Goat Cyber! Very knowledgeable and professional. Would work with again without hesitation!"
If the FDA raises a cybersecurity deficiency, we fix it at no additional cost. 275+ devices supported.
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. Revisions included. 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 275+ devices supported. Author of three books including Medical Device Cybersecurity: An In-Depth Guide.
30-minute call with a senior medical device cybersecurity expert. Fixed-fee program quote within 24 hours of the call. Fixed-fee retainer, no per-CVE billing.
