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. 275+ FDA submissions supported, zero cybersecurity rejections.
Postmarket program scope: SBOM monitoring, vulnerability triage, evidence-based VEX, coordinated disclosure, and patch governance for devices on the market.
Request a written scope instead275+ FDA submissions supported, zero cybersecurity rejections.
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Trusted by medical device teams worldwide
The proposal identifies included deliverables, exclusions, manufacturer inputs, and review responsibilities for this engagement.
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 response times, and disclosure coordination aligned to ISO/IEC 29147 and 30111. Dates and approval responsibilities are agreed in scope.
Your shipping SBOM is matched daily in GoatWatch, our purpose-built postmarket platform, against NVD, CISA KEV, and vendor advisories. New CVEs are assessed against device evidence. VEX statuses and customer communications require manufacturer review; they are not inferred automatically.
Decision framework for emergency patches, planned updates, and end-of-support, every decision documented and audit-ready.
Assess reporting under 21 CFR Parts 803 and 806, including applicable exceptions and enforcement discretion. We provide technical assessment and drafting support; the manufacturer owns reportability and submission decisions.
Monthly retainer or annual fixed fee. No per-CVE invoicing. Every quarter you get a written postmarket program review.
These are program evidence review areas, not predictions of findings or inspection outcomes.
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.
Uncontrolled risk requires prompt manufacturer action and separate assessment of Parts 803 and 806 reporting. Risk classification alone does not establish a reporting obligation.
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) | Applicable obligations mapped to scoped evidence | 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 | Agreed monitoring; manufacturer-approved VEX | 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 |
| Reporting cadence and evidence exports | Agreed cadence, documented evidence | Tickets only, no narrative | Pulled together at audit time |
Discuss architecture, available records, access, responsibilities, and target dates. Agree confidential handling before transferring device material.
The proposal identifies included work, exclusions, manufacturer inputs, and delivery milestones. The 24-hour quote turnaround is separate from delivery, remediation, and review time.
Monitor the agreed device inventory and vulnerability sources. Support triage, evidence-based VEX, disclosure, and patch decisions within agreed response times. The manufacturer approves risk and reporting decisions.
Your team approves vulnerability assessments, VEX statements, updates, and reporting decisions. Monitoring and response dates are agreed in the program scope.
We sign a mutual NDA before the initial call so you can share device details, architecture, and FDA correspondence freely.
The quote identifies deliverables, assumptions, and dates. Quote turnaround is separate from the time needed to deliver the work.
Senior-led cybersecurity work within the agreed scope. Your team reviews the evidence and owns risk, release, and submission decisions.
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+ FDA submissions supported, zero cybersecurity rejections. 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. No per-CVE billing.
