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 Approval Is Only the Beginning
Getting your device to market is a significant milestone, but staying secure and compliant 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 approval.
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 approval, with a full suite of services built to reduce risk, ensure regulatory alignment, and support your device throughout its 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.
Trusted by Medical Device Manufacturers Worldwide
“Blue Goat Cyber’s SBOM monitoring and custom postmarket portal gave us unprecedented visibility into our devices’ cybersecurity. Their annual contract ensures we stay ahead of risks and compliant year-round.”
— Chief Technology Officer, Global Medical Device Manufacturer
“Their proactive monitoring and immediate response to emerging vulnerabilities have been critical for keeping our devices secure postmarket. The custom portal has streamlined our tracking process.”
— Director of Quality Assurance, IoT Medical Device Company
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.
