Secure Your Medical Devices Postmarket with Comprehensive Cybersecurity Solutions
From real-time threat monitoring to legacy device security, our tailored solutions help you protect patients, maintain compliance, and stay ahead of evolving cyber risks.
Postmarket Cybersecurity: Critical for Device Safety and Compliance
The challenges of cybersecurity don’t end once your medical device receives FDA approval. Postmarket risks, including emerging vulnerabilities and compliance requirements, must be proactively managed to ensure patient safety and regulatory adherence. Without a comprehensive postmarket cybersecurity strategy, manufacturers face:
- Regulatory Penalties: Non-compliance with FDA postmarket guidance can lead to recalls, warnings, or fines.
- Patient Safety Risks: Exploited vulnerabilities can compromise device functionality and harm patients.
- Reputational Damage: A cybersecurity incident can erode trust in your devices and your brand.
Blue Goat Cyber’s postmarket cybersecurity solutions are designed to address these challenges head-on. We help you monitor threats, manage vulnerabilities, and ensure your devices remain safe and compliant throughout their lifecycle.
Protect your devices postmarket with tailored solutions. Schedule a free Discovery Session today.
Tailored Solutions for Device Security and Lifecycle Compliance
We offer comprehensive postmarket cybersecurity services to help medical device manufacturers meet regulatory requirements and protect patient safety. From monitoring to legacy device security, our services are designed to keep your devices secure and operational in an ever-evolving threat landscape.
Postmarket Cybersecurity Management
- Real-Time Threat Monitoring: Detect vulnerabilities and respond to emerging threats quickly to maintain patient safety.
- Incident Response and Recovery: Minimize downtime and regulatory impact with a robust response plan for cybersecurity events.
- Regulatory Compliance: Align with FDA postmarket cybersecurity guidance, ensuring your devices meet ongoing safety and effectiveness standards.
Legacy Device Cybersecurity Services
- Risk Assessment for Legacy Devices: Identify and address vulnerabilities in older devices that may not meet modern cybersecurity standards.
- Custom Security Solutions: Implement tailored protections to extend the lifecycle of legacy devices while maintaining safety and compliance.
- Regulatory Alignment: Ensure legacy devices meet FDA postmarket guidance and global standards.
- Cost-Effective Strategies: Reduce the need for costly redesigns or replacements while keeping devices secure.
Your Trusted Partner for Postmarket Cybersecurity
Specialized Expertise
Over a decade of experience dedicated to medical device cybersecurity, including postmarket and legacy device management.
Regulatory Alignment
Full compliance with FDA postmarket guidance, IEC 62304, AAMI TIR97, and ISO 14971 ensures your devices meet ongoing requirements.
Proactive Protection
Real-time monitoring and incident response capabilities keep your devices secure from emerging threats.
Cost-Effective Legacy Solutions
Specialized services for legacy devices allow you to maintain compliance and security without the expense of replacement.
Comprehensive Support
From threat monitoring to lifecycle management, we provide end-to-end postmarket cybersecurity solutions.
Comprehensive Postmarket Cybersecurity Management
✅ Postmarket Monitoring
We continuously monitor for emerging vulnerabilities and security threats that could impact your device, ensuring proactive risk management and regulatory compliance.
✅ Annual Vulnerability Assessment & Penetration Testing
Regular security assessments help identify new risks that could compromise patient safety, allowing you to stay ahead of threats before they become a problem.
✅ Remediation Validation Testing
If a vulnerability is identified, we validate that remediation efforts effectively eliminate the risk, ensuring your device remains secure and compliant.
✅ Static Application Security Testing (SAST)
We conduct regular software security testing to identify vulnerabilities in your firmware, software, and applications, ensuring your device remains hardened against threats.
✅ SBOM Hosting & Continuous Monitoring
We provide secure hosting for your Software Bill of Materials (SBOM) and offer continuous monitoring for emerging vulnerabilities in your third-party components.
✅ Coordinated Vulnerability Disclosure Portal Hosting & Maintenance
Our team manages a secure vulnerability disclosure portal, ensuring you comply with FDA postmarket cybersecurity expectations and maintain transparency with regulators, customers, and security researchers.
✅ CISA KEV Catalog Tracking
We monitor the Cybersecurity & Infrastructure Security Agency’s (CISA) Known Exploited Vulnerabilities (KEV) catalog, helping you identify and respond to vulnerabilities that could affect your device’s security.
Trusted by Leading Medical Device Manufacturers
“Blue Goat Cyber’s postmarket monitoring solutions gave us confidence in the ongoing security of our devices. Their proactive approach and incident response capabilities have been invaluable.”
— CTO, Global Medical Device Manufacturer
“Our legacy devices were a constant challenge until we partnered with Blue Goat Cyber. Their tailored security solutions helped us protect these older systems while staying compliant with FDA guidance.”
— VP of Quality Assurance, Medical Device Company
Start securing your devices postmarket. Schedule your free Discovery Session today.
A Simple Path to Postmarket Security and Compliance
Discovery Session: We learn about your devices, their current vulnerabilities, and your postmarket needs.
Customized Postmarket Strategy: Our experts design a tailored plan for threat monitoring, patch management, and legacy device security.
Implementation and Monitoring: We deploy solutions, monitor your devices in real-time, and ensure compliance with FDA postmarket guidance.
Ongoing Support: Receive continuous updates, assessments, and incident response support to protect your devices and patients.
Securing your medical devices postmarket is critical to patient safety, compliance, and brand trust. With Blue Goat Cyber’s tailored solutions, you can stay ahead of emerging threats, manage vulnerabilities, and protect your devices throughout their lifecycle.
