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.
The short answer
Once a cyber device is on the market, Section 524B expects you to follow the management plan you submitted: monitor for new vulnerabilities, assess them for patient-harm risk, disclose them in a coordinated way and ship updates and patches on a reasonable schedule. We match your SBOM against new vulnerability data daily, triage what affects the device, support coordinated disclosure and keep your management plan and SBOM current.
Preserves FDA Compliance. Year-Round Protection.
Trusted by leading MedTech companies
The cycle
SBOM · advisories · reports
New issues spotted early
Exploitability · patient impact
Documented risk decision
Fixes · controls · validation
Updates delivered safely
Customers · regulators · records
Then the cycle repeats
Section 524B(b)(1) and the FDA's 2016 postmarket cybersecurity guidance establish what a postmarket program must produce. Each item below is in scope when we run the program end-to-end.
Layers shown outermost (top) to innermost (bottom). Dashed rows are part of the surrounding system but out of scope for this view.
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 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.
Recommends risk-based cybersecurity evidence, including threat modeling, architecture views, and testing. An SPDF is encouraged, not mandatory; Section 524B separately establishes statutory duties for covered cyber devices.
Statutory duties for cyber devices on covered 510(k), De Novo, PMA, PDP, and HDE pathways: a postmarket vulnerability plan, cybersecurity and update processes, and an SBOM. IDE applications are not Section 524B submissions.
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.
Recalls, CISA ICS-MA advisories, and disclosed research that shape what reviewers ask about, and what this engagement is built to cover.
A missing or vague postmarket cybersecurity management plan is a Refuse-to-Accept trigger for new submissions under Section 524B(b)(1). The Feb 3, 2026 final guidance is more prescriptive on what the plan must contain than the 2023 draft.
The event that exposed which manufacturers had a working postmarket program and which did not. SBOM + VEX + a real CVD intake became table stakes after this.
Reduce risk on fielded devices - no redesign, no new submission, no downtime.
View Legacy Device ProtectionOne package for applicable FDA cybersecurity documentation, threat modeling, SBOMs, testing, and submission support.
View FDA Premarket Cybersecurity PackageCybersecurity content for Predetermined Change Control Plans, for AI/ML and non-AI devices.
View PCCP Cybersecurity ServicesSee 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.
Long-form reference reading, architecture, frameworks, and end-to-end how-tos.
Shorter posts on the specific gotchas, deficiencies, and reviewer expectations we see most.
Pressure-test the work yourself before you scope an engagement. No signup, results are yours to keep.
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.
Monitoring starts the day the contract is signed. Testing waits for your software. Everything below runs as one continuous service with a single scheduled test event, not a series of separate purchases.
Rehearse how your team would respond to a cybersecurity incident affecting a marketed device. A facilitated, discussion-based exercise walks engineering, product security, regulatory, quality, and customer-facing teams through a scenario tied to your device and response plan. It is a practice drill, not penetration testing or a live attack against your device.
Can be included with your postmarket retainer, with scope agreed in your proposal. Standalone or additional exercise pricing depends on exercise scope, delivery location, on-site requirements, and other engagement requirements.
See scenarios and book a tabletop exerciseThe test event is the only item tied to your release. It is scheduled two weeks after you confirm validation is complete; everything else runs from signing.
New threats emerge daily as your medical device operates in a connected world. Without a proactive postmarket cybersecurity strategy, the stakes are high.
Failure to meet applicable regulatory obligations can result in warning letters, recalls, or enforcement action. The December 28, 2016 FDA postmarket guidance provides nonbinding recommendations.
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, supporting manufacturer-owned risk assessment and applicable regulatory obligations 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 daily 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, matched against new vulnerabilities daily.
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.
Included with every annual postmarket contract - no separate procurement.
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 |
|---|---|---|---|
Annual Penetration Test Internal teams almost never have offensive security skill sets in-house | ⚠ | ⚠ | |
Annual Static Application Security Testing (SAST) Tools exist, but tuning, triage, and patient-safety context are the hard parts | ⚠ | ⚠ | |
Continuous SBOM Monitoring Spreadsheets break down at scale | ⚠ | ⚠ | |
Real-Time CVE & Vulnerability Alerts NVD feeds are free; correlating them to your devices every day is the work | ⚠ | ⚠ | |
CVD Portal Setup & Operation Standing up a CVD program requires legal, comms, and triage workflows | ✕ | ⚠ | |
Patient-Safety Risk Triage (ISO 14971 ↔ Cyber) Bridging cyber and risk management requires both disciplines on one team | ⚠ | ✕ | |
CISA / ICS-CERT Coordination & Advisories | ✕ | ✕ | |
Incident Response & Recovery Playbooks Most internal IR plans aren't built for medical device patient-safety scenarios | ⚠ | ⚠ | |
Legacy Device Mitigation Strategy Compensating controls for unpatchable devices is specialist work | ✕ | ✕ | |
Wireless / BLE / RF Postmarket Surveillance Requires specialized RF tooling and expertise | ✕ | ✕ | |
Cloud Backend & Mobile Companion App Monitoring | ⚠ | ⚠ |
What actually keeps you compliant after clearance.
| Capability | Blue Goat Cyber ★ | Internal Team | Typical Vendor |
|---|---|---|---|
FDA 2016 Postmarket Guidance and §524B Aligned Operationalizing it is months of work | ⚠ | ⚠ | |
MDR (21 CFR 803) Reporting Decisions RA/QA teams handle MDRs but rarely have cyber-event reporting experience | ⚠ | ✕ | |
Part 806 Correction & Removal Reporting | ⚠ | ✕ | |
QMS Integration (21 CFR 820, ISO 13485) Your QMS team can wire it in, but cyber-specific procedures need to be authored | ⚠ | ✕ | |
AAMI SW96 / TIR57 / TIR97 Alignment | ⚠ | ⚠ | |
EU MDR / IVDR Postmarket Surveillance (MDCG 2019-16) | ⚠ | ✕ | |
Audit-Ready Evidence & Reporting Doable internally, but eats hundreds of hours per audit cycle | ⚠ | ⚠ |
How we work, and why it removes risk for you.
| Capability | Blue Goat Cyber ★ | Internal Team | Typical Vendor |
|---|---|---|---|
Annual Fixed-Fee Cost Internal cost = 1-2 FTE salaries + tooling, typically 3-5x our annual fee | ✕ | ⚠ | |
GoatWatch Portal Included Building an equivalent in-house is a multi-quarter project | ✕ | ✕ | |
275+ Devices Successfully Cleared Track record across startups to Intuitive Surgical, bioMérieux, Inogen, Natera | ✕ | ⚠ | |
Senior Expert Leads Your Engagement Hiring a senior medical device security engineer is hard and expensive | ⚠ | ⚠ | |
Service-Disabled Veteran-Owned (SDVOSB) Federally certified, advantageous for federal MedTech contracts | ✕ | ✕ | |
Full-Service (No Subcontractors) | ⚠ | ⚠ | |
Start This Week (Not Next Quarter) Hiring and ramping an internal team takes 6-12 months | ✕ | ⚠ |
"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."
From startups to global leaders.
Da Vinci-class platforms, autonomous orthopedic systems, and minimally-invasive surgical robots. Postmarket focus on real-time control plane integrity, vendor firmware patching cadence, and SBOM monitoring across third-party stacks (RTOS, vision, networking).
Connected point-of-care analyzers and remote diagnostic stations. We monitor CVEs in the embedded Linux base, cloud APIs, and BLE/Wi-Fi stacks, and produce the postmarket evidence reviewers expect under Section 524B(b)(1).
Cardiac, neurostimulation, and infusion implantables with wireless interfaces. Risk-based vulnerability triage tied to clinical hazard, plus CVD-aligned coordinated disclosure handling for finder reports against the device or its programmer.
Continuous glucose monitors, ECG patches, and remote patient monitoring wearables. SBOM surveillance covers the companion mobile app, BLE link, and cloud backend - the surfaces most often missed by IT-style postmarket programs.
High-throughput molecular and immunoassay analyzers with LIS/EMR integration. Patch governance for Windows/Linux instrument controllers, HL7/ASTM interface hardening, and FDA-aligned change-control documentation.
Imaging AI, clinical decision support, and triage SaMD. Postmarket monitoring extends to model artifacts, training-data pipelines, and PCCP-tracked changes - mapped to the FDA's AI/ML guidance and 2026 premarket framework.
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)
MedTech World North America
