Stay ahead of CVEs.Audit-ready always.
GoatWatch continuously monitors your medical device SBOMs for new vulnerabilities, prioritizes what actually matters, and produces audit-ready evidence for FDA postmarket cybersecurity — without the noise.
Built by the team behind 250+ FDA submissions. Zero rejections.
- Free 30-min call
- No obligation
- Senior expert, not a sales rep
- Fixed-fee quote in 24 hours
- NDA available on request
The MedTech SBOM Compliance Playbook
What FDA actually expects for SBOMs, vulnerability monitoring, and postmarket cybersecurity — in plain English, with templates you can use this week.
- The 2023 Refuse-to-Accept rule, decoded
- Five SBOM artifacts every submission needs
- Continuous monitoring without the noise
- A 90-day compliance roadmap
Aligned to FDA's Section 524B postmarket cybersecurity guidance.
MedTech compliance standards we follow
What GoatWatch does for you
Whether you need premarket SBOM creation or postmarket continuous monitoring, GoatWatch covers both — standalone or as part of our full postmarket service.
Real-Time CVE Detection
GoatWatch continuously scans your SBOM components against the NVD and vendor advisories, alerting your team the moment a new vulnerability is published.
Device-Context Triage
Not every CVE matters equally. GoatWatch scores and prioritizes vulnerabilities based on your specific device architecture, reducing alert fatigue.
Audit-Ready Evidence
Generate compliance artifacts and postmarket surveillance documentation that satisfy FDA, IEC 81001-5-1, and EU MDR/IVDR on demand.
Premarket SBOM Support
We analyze and build your SBOM for premarket submissions — structured, machine-readable, and aligned with FDA cybersecurity guidance.
Postmarket Monitoring
After launch, GoatWatch keeps watching. Track emerging threats, manage patches, and maintain continuous compliance throughout the device lifecycle.
Submission Track Record
Built by the team behind 250+ FDA submissions with zero rejections — the same people will run your monitoring program.
Premarket help, postmarket peace of mind.
FDA expects SBOM rigor before clearance — and continuous vigilance after launch. GoatWatch covers both sides of the lifecycle.
Submission-Ready SBOMs
Build a complete, FDA-aligned SBOM before you submit. We help you validate component data, resolve unknowns, and produce a baseline cybersecurity risk assessment that holds up under review.
- CycloneDX & SPDX validation
- Known-vulnerability baseline
- Submission documentation pack
Continuous CVE Monitoring
After clearance, your SBOM keeps working. GoatWatch monitors every component daily, prioritizes exploitable risks, and gives you the evidence trail regulators expect.
- Daily CVE & KEV matching
- VEX-ready triage workflow
- Audit logs for postmarket reporting
From SBOM to evidence in four steps
Import Your SBOM
Upload or generate your SBOM — we support CycloneDX, SPDX, and custom formats.
Analyze & Map Risks
GoatWatch maps every component to known CVEs, vendor advisories, and end-of-life status.
Monitor Continuously
Post-launch, receive prioritized alerts when new vulnerabilities affect your device.
Export Evidence
Generate audit-ready reports for FDA postmarket submissions and compliance reviews.
GoatWatch vs generic SBOM scanners & DIY tracking
A side-by-side look at what you actually get with continuous, med-device-specific SBOM monitoring.
| Capability |
GoatWatch★ Recommended
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Generic Scanner / DIY(industry average)
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|---|---|---|
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1
SBOM Coverage
How completely your software supply chain is mapped.
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SPDX & CycloneDX Ingestion
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SBOM Generation if You Don't Have One
Most scanners assume you already have a clean SBOM
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Component Normalization & Version Resolution
Raw SBOMs are noisy. We clean them before monitoring.
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Firmware & Embedded Component Tracking
DIY trackers and IT-focused scanners miss firmware components
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2
Vulnerability Triage
Turning raw CVE noise into decisions your team can act on.
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Continuous CVE & Advisory Monitoring
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Device-Context Impact Triage
We factor in network exposure, exploitability, and clinical risk — not just CVSS
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Patient-Safety Linked (ISO 14971)
Cyber risk tied to patient harm, not just data confidentiality
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Vendor Advisory & EOL Tracking
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Expert-Led Triage (Not Just a Dashboard)
A senior med-device cyber expert reviews findings with you
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3
Regulatory & Audit Readiness
What FDA reviewers and notified bodies actually expect.
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FDA Postmarket Cyber Guidance Aligned
Section 524B, RTA-ready evidence
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IEC 62304 / IEC 81001-5-1 Mapping
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EU MDR Postmarket Surveillance Support
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Audit-Ready Vulnerability Timelines
Triage decisions, remediation actions, SBOM change history
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Exportable Evidence Packs
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4
Service & Terms
How we work — built for med-device teams, not enterprise IT.
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Senior MedTech Cyber Expert Assigned
Not a junior analyst, not a generic SOC tier-1
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Fixed-Fee Pricing per Device
No hourly billing, no scope creep
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Onboarding in 1–2 Weeks
Enterprise SBOM platforms typically take months
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SDVOSB Certified Vendor
Federally certified, advantageous for federal MedTech contracts
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Standalone or Bundled with Postmarket Service
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From first call to continuous monitoring in 2 weeks
Most SBOM platforms put you in a multi-month onboarding queue. We start this week.
Discovery Call
Talk directly with a senior medical device cyber expert. We learn your device, SBOM status, and postmarket risk profile — no sales reps.
SBOM Onboarding
We ingest your existing SBOM (SPDX/CycloneDX) or generate one. Components are normalized, version-resolved, and mapped to your device context.
Continuous Monitoring Live
GoatWatch goes live, tracking CVEs, vendor advisories, and EOL notices. Triage rules tuned to your risk profile, alerts routed to your team.
Audit-Ready Evidence
Vulnerability timelines, triage decisions, remediation actions, and SBOM change history — exportable for FDA, notified bodies, and internal QMS.
Trusted by MedTech security teams
"GoatWatch gave us visibility into our SBOM risks that we simply didn't have before. When the FDA asked about our postmarket surveillance process, we had audit-ready evidence on day one."
VP of Regulatory Affairs
Class III Medical Device Manufacturer
"We used to track CVEs in spreadsheets, and it was a nightmare. GoatWatch's device-context triage means we focus on real threats, not noise. It has been a game-changer for our team."
Director of Product Security
Connected Health Platform
"Blue Goat handled our premarket SBOM analysis and transitioned us seamlessly into GoatWatch for postmarket monitoring. The continuity from submission to surveillance is exactly what we needed."
Head of Quality & Compliance
Surgical Robotics Company
GoatWatch questions
Need more than monitoring?
GoatWatch is one piece of our full medical device cybersecurity offering.
Already have an SBOM? Let's monitor it.
30 minutes with a senior medical device cybersecurity expert. We'll review your SBOM, scope ongoing monitoring, and send a fixed-fee quote in 48 hours.