Postmarket Cybersecurity That Protects Patients and Preserves FDA Compliance
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.
Trusted by Leading MedTech Startups and Manufacturers Since 2014
MedTech Industry Compliance Standards We Follow
ISO 14971 • FDA Guidance • UL 2900 • AAMI TIR57 • NIST 800-115 • IEC 62304 • ISO 13485 • AAMI TIR97 • ISO 27001 • IEC 81001-5-1 • IEC 62443-4-1
FDA Clearance is Only the Beginning
Reaching the market with your device is a significant milestone, but maintaining security and compliance is an ongoing challenge. New threats emerge daily as your medical device operates in a connected world. Without a proactive postmarket cybersecurity strategy, you risk more than technical issues.
⚠️ The Stakes Are High
📄 Regulatory Risk
Non-compliance with FDA postmarket guidance can result in warning letters, recalls, or enforcement action.
🛑 Patient Safety Threats
Cyber vulnerabilities can impair device performance, putting lives at risk.
💸 Business Impact
Breaches damage your brand, delay product updates, and increase operational costs.
✅ Why It Matters Now
Managing these risks isn’t optional—it requires ongoing oversight, specialized tools, and expert support to stay ahead of threats and align with FDA expectations.
🔵 Keep Your Devices Secure — and Your Compliance Solid
Get a tailored roadmap to monitor vulnerabilities, manage risks, and protect your devices long after clearance.
Get expert insight on your SBOM, threat readiness, and FDA alignment.
Postmarket Protection That Keeps Your Devices Safe, Compliant, and Resilient
Postmarket cybersecurity isn’t optional — protecting patients, preserving compliance, and maintaining trust is essential.
At Blue Goat Cyber, we specialize in securing medical devices after FDA clearance, offering a comprehensive suite of services designed to reduce risk, ensure regulatory alignment, and support your device throughout its entire lifecycle.
What We Deliver — and Why It Sets Blue Goat Cyber Apart
🧩 SBOM Monitoring & Management
We continuously track your Software Bill of Materials (SBOM) to detect and respond to vulnerabilities in third-party and open-source components, ensuring FDA and global regulatory compliance, even as risks evolve.
📊 Custom Postmarket Tracking Portal
Gain full visibility with a secure dashboard that tracks vulnerabilities, patches, and incidents — giving your team real-time insight into device performance, cybersecurity posture, and compliance status.
⚠️ Real-Time Threat Monitoring & Response
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.
🛡️ Incident Response & Recovery Plans
When an event occurs, we’re ready. Our proven response playbooks minimize downtime, ensure audit-ready documentation, and protect your patients — and your brand.
♻️ Legacy Device Security Solutions
We extend the lifecycle of your older devices with tailored risk mitigation strategies — balancing safety, functionality, and compliance without requiring full redesigns.
📅 Annual Contract — Continuous Protection & Peace of Mind
Get full-lifecycle coverage with a postmarket cybersecurity contract that includes 24/7 monitoring, regular updates, reporting, and expert guidance — so you can focus on innovation, not firefighting.
✅ Why It’s Different:
At Blue Goat Cyber, we don’t just monitor — we manage. We don’t just assess — we solve. And we don’t just scan — we guide you through FDA-aligned, patient-centric cybersecurity for the long haul.
Why Leading MedTech Companies Choose Blue Goat Cyber
🎯 Exclusive Focus on Medical Devices
Over a decade dedicated solely to securing medical technologies — from diagnostics to robotics. No distractions. No generalist fluff. Just deep MedTech cybersecurity expertise.
📜 Aligned with FDA and Global Standards
We build every strategy to meet FDA postmarket guidance and align with ISO 14971, AAMI TIR97, and IEC 62304 — reducing audit risk and giving regulators exactly what they expect.
🔍 Leaders in SBOM Monitoring & Management
We continuously track third-party and open-source components to protect against supply chain risks — keeping your SBOM current, secure, and inspection-ready.
📊 Proprietary Postmarket Cyber Portal
Our custom dashboard gives your team real-time visibility into threats, patches, and compliance, so you’re always audit-ready and in control.
🔄 Lifecycle-Driven Risk Protection
We don’t stop at checklists. We address threats across the entire device lifecycle — supporting updates, threat response, and patient safety long after launch.
🛡 Proven by Results, Trusted by Industry
Startups. Global manufacturers. Everyone in between. Leading MedTech companies trust Blue Goat to secure their devices, maintain compliance, and protect their reputation.
Partner with Blue Goat Cyber for a comprehensive postmarket solution.
We’ve partnered with manufacturers of all sizes—from startups to global leaders for FDA postmarket management services for devices like:
- Robotic surgical systems
- IoT-enabled diagnostic tools
- Implantable medical devices
- Wearable health technology
- Complex IVD systems
- AI-Enabled SaMD
Recent Client Feedback
How to Secure Your Devices Postmarket with Blue Goat Cyber
- Schedule a Discovery Session: We’ll discuss your device’s postmarket cybersecurity needs and challenges.
- Get a Customized Plan: We’ll develop a comprehensive postmarket strategy, including SBOM monitoring, threat detection, and patch management.
- Stay Secure Year-Round: With our annual contract and custom postmarket portal, you’ll have continuous support and visibility to keep your devices compliant and secure.
Blue Goat Cyber's Postmarket Cybersecurity Management Service FAQs
Blue Goat Cyber provides ongoing postmarket cybersecurity support built around FDA expectations—typically including SBOM monitoring, vulnerability response planning, and continuous security oversight for marketed medical devices.
Yes. Blue Goat monitors your SBOM to identify newly disclosed vulnerabilities in third-party and open-source components, so you can quickly determine impact and take action.
It’s a centralized portal that gives your team visibility into postmarket cybersecurity status—tracking vulnerabilities, patches, and incidents so nothing gets lost and your records stay audit-ready.
Yes. Blue Goat provides active threat monitoring and response support designed to help you identify threats early and reduce the chance they impact device functionality or patient care.
Yes. Blue Goat helps you run a structured vulnerability management process—triage, risk decisions, remediation planning, and documentation—so you’re not handling issues in an ad hoc way.
Yes. Blue Goat provides incident response and recovery planning using established playbooks to reduce downtime and produce clear, defensible documentation.
Yes. Blue Goat offers legacy device security support, focusing on practical mitigations and risk-reduction strategies when full patching or redesign isn’t realistic.
Blue Goat offers ongoing postmarket support structured as an annual service engagement, with monitoring options that can include 24/7 coverage depending on your needs.
The program is aligned with FDA postmarket expectations and commonly used medtech standards, such as ISO 14971, AAMI TIR97, and IEC 62304—so your approach is defensible and familiar to reviewers and auditors.
It typically starts with a discovery session to understand your device, architecture, and postmarket risks. From there, Blue Goat builds a customized plan (including monitoring, SBOM, vulnerability response, and patch planning) and sets up ongoing reporting and workflows.