We help medical device companies stay compliant, secure, and resilient with FDA-aligned SBOM tracking, vulnerability response plans, and ongoing threat monitoring tailored to your devices.
Preserves FDA Compliance. Year-Round Protection.
Trusted by leading MedTech companies
An ongoing annual engagement run by a named senior engineer - not a platform subscription.
We audit your current SBOM, document your threat landscape, and set up monitoring infrastructure tailored to your device fleet.
Continuous SBOM tracking, CVE alerting, and threat monitoring run in the background - flagged to your team when action is required.
When a vulnerability is disclosed or an incident occurs, we manage the triage, remediation, and FDA notification process.
Quarterly compliance reports give you a documented record of your postmarket cybersecurity programme - audit-ready at any point.
Every fda postmarket cybersecurity engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.
Every fda postmarket cybersecurity engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.
Defines the SPDF, Section 524B submission package, threat modeling, SBOM, security architecture views, and cybersecurity testing every cyber device submission must include.
Statutory requirement that every cyber device 510(k), De Novo, PMA, and IDE submission include a complete cybersecurity package or face Refuse to Accept (RTA).
Postmarket companion to TIR57/SW96 - CVE monitoring, vulnerability triage, patching, and coordinated disclosure.
The consensus standard for medical device security risk management - asset, threat, vulnerability, likelihood, severity, and residual risk acceptability.
Foundational risk management standard. Cybersecurity risk is tied directly to patient-safety risk in the 14971 file.
International QMS standard for medical devices. Cybersecurity deliverables are designed to slot into your existing 13485 QMS without parallel paperwork.
New threats emerge daily as your medical device operates in a connected world. Without a proactive postmarket cybersecurity strategy, the stakes are high.
Non-compliance with FDA postmarket cybersecurity guidance can result in warning letters, recalls, or enforcement action.
Cyber vulnerabilities can impair device performance, putting lives at risk in clinical environments.
Breaches damage your brand, delay product updates, and increase operational costs significantly.
Designed to reduce risk, ensure regulatory alignment, and support your device throughout its entire lifecycle.
Continuously track your Software Bill of Materials to detect and respond to vulnerabilities in third-party and open-source components, ensuring FDA and global regulatory compliance even as risks evolve.
Gain full visibility with a secure dashboard that tracks vulnerabilities, patches, and incidents in real-time, giving your team complete insight into device performance, posture, and compliance status.
We don't wait for alerts. We actively monitor cyber threats across your ecosystem, enabling fast mitigation of vulnerabilities before they impact device functionality or patient safety.
Proven response playbooks that minimize downtime, ensure audit-ready documentation, and protect your patients and brand when an event occurs.
Extend the lifecycle of older devices with tailored risk mitigation strategies, balancing safety, functionality, and compliance without requiring full redesigns.
Full-lifecycle coverage with 24/7 monitoring, regular updates, reporting, and expert guidance so you can focus on innovation, not firefighting.
We don't just monitor. We manage. We don't just assess. We solve.
Every annual postmarket management contract includes access to GoatWatch, our purpose-built monitoring platform for medical device manufacturers. Track SBOMs, surface vulnerabilities, and generate FDA-aligned evidence, all from a single secure dashboard.
No extra fees. No separate procurement. Just continuous protection from day one.
Automated scanning of every component in your device's Software Bill of Materials, 24/7.
Instant notifications the moment a CVE is published affecting any of your monitored devices.
Audit-ready reports and exportable evidence aligned with FDA postmarket guidance.
Each vulnerability is assessed in clinical context with prioritized remediation steps.
No à la carte invoices. No "that's a separate engagement." It's all in.
No vague promises. Compare us to building an internal team or hiring a typical vendor.
The ongoing cybersecurity work that keeps cleared devices safe and compliant.
| Capability | Blue Goat Cyber ★ | Internal Team | Typical Vendor |
|---|---|---|---|
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Annual Penetration Test
Internal teams almost never have offensive security skill sets in-house
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Annual Static Application Security Testing (SAST)
Tools exist, but tuning, triage, and patient-safety context are the hard parts
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Continuous SBOM Monitoring
Spreadsheets break down at scale
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Real-Time CVE & Vulnerability Alerts
NVD feeds are free; correlating them to your devices 24/7 is the work
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CVD Portal Setup & Operation
Standing up a CVD program requires legal, comms, and triage workflows
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Patient-Safety Risk Triage (ISO 14971 ↔ Cyber)
Bridging cyber and risk management requires both disciplines on one team
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CISA / ICS-CERT Coordination & Advisories
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Incident Response & Recovery Playbooks
Most internal IR plans aren't built for medical device patient-safety scenarios
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Legacy Device Mitigation Strategy
Compensating controls for unpatchable devices is specialist work
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Wireless / BLE / RF Postmarket Surveillance
Requires specialized RF tooling and expertise
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Cloud Backend & Mobile Companion App Monitoring
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What actually keeps you compliant after clearance.
| Capability | Blue Goat Cyber ★ | Internal Team | Typical Vendor |
|---|---|---|---|
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FDA 2026 Postmarket Guidance Aligned
Operationalizing it is months of work
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MDR (21 CFR 803) Reporting Decisions
RA/QA teams handle MDRs but rarely have cyber-event reporting experience
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Part 806 Correction & Removal Reporting
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QMS Integration (21 CFR 820, ISO 13485)
Your QMS team can wire it in, but cyber-specific procedures need to be authored
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AAMI SW96 / TIR57 / TIR97 Alignment
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EU MDR / IVDR Postmarket Surveillance (MDCG 2019-16)
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Audit-Ready Evidence & Reporting
Doable internally, but eats hundreds of hours per audit cycle
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How we work, and why it removes risk for you.
| Capability | Blue Goat Cyber ★ | Internal Team | Typical Vendor |
|---|---|---|---|
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Annual Fixed-Fee Cost
Internal cost = 1-2 FTE salaries + tooling, typically 3-5x our annual fee
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GoatWatch Portal Included
Building an equivalent in-house is a multi-quarter project
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250+ Devices Successfully Cleared
Track record across startups to Intuitive Surgical, bioMérieux, Inogen, Natera
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Senior Expert Assigned (No Junior Handoff)
Hiring a senior medical device security engineer is hard and expensive
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Service-Disabled Veteran-Owned (SDVOSB)
Federally certified, advantageous for federal MedTech contracts
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Full-Service (No Subcontractors)
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Start This Week (Not Next Quarter)
Hiring and ramping an internal team takes 6-12 months
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From startups to global leaders.
Our team holds the offensive security certifications real attackers respect, backed by hands-on U.S. government red team and military cyber operations experience.
Our work has been honored by the leading voices in medical device cybersecurity.
Medical Tech Outlook (cover story)
MedTech World Malta 2025 (sponsored by the Malta Medicines Authority)
Healthcare Business Review
Reduce risk on fielded devices - no redesign, no new submission, no downtime.
Learn moreFull-service: we own 100% of SPDF, SBOMs, threat modeling, pen testing, and eSTAR documentation.
Learn moreGot an FDA hold or AI letter? We close cybersecurity deficiencies fast.
Learn moreSee how this service applies to your specific MedTech segment.
Curated reading for teams working on postmarket cybersecurity - grouped by format so you can jump to what you need.
"Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
We help medical device companies stay compliant, secure, and resilient with FDA-aligned SBOM tracking, vulnerability response plans, and ongoing threat monitoring tailored to your devices.
