FDA approval is just the beginning of your medical device’s journey. As your device operates in a rapidly evolving digital environment, new vulnerabilities emerge, exposing it to cyber threats. Without a proactive postmarket strategy, manufacturers face:
Managing these challenges requires ongoing oversight, customized tools, and expert guidance to keep your devices secure throughout their lifecycle.
Ensure your devices stay secure and compliant. Schedule a free Discovery Session today.
At Blue Goat Cyber, we understand the unique challenges of securing medical devices postmarket. That’s why we offer a comprehensive suite of services designed to protect your devices, maintain compliance, and reduce risk at every stage of the product lifecycle.
Proactively monitor your Software Bill of Materials (SBOM) to identify and address vulnerabilities in third-party and open-source components, ensuring compliance with FDA and global regulations.
Our dedicated portal provides real-time insights into device performance, cybersecurity risks, and compliance status. Track vulnerabilities, patches, and incidents with complete transparency and control.
Real-time detection of new vulnerabilities and cyber threats, with immediate response capabilities to protect devices and maintain patient safety.
Rapid and thorough response to cybersecurity events to minimize downtime, ensure compliance, and protect your reputation.
Tailored solutions to address vulnerabilities in older devices, extending their lifecycle while maintaining safety and compliance.
Enjoy peace of mind with our annual postmarket cybersecurity contract, offering continuous support, monitoring, and updates to ensure your devices remain secure and compliant year-round.
Over 10 years of experience dedicated exclusively to medical device cybersecurity.
Full compliance with FDA postmarket guidance, ISO 14971, AAMI TIR97and IEC 62304 standards, ensuring your devices meet regulatory requirements.
Continuous tracking and management of software components to protect against supply chain vulnerabilities and regulatory scrutiny.
Gain visibility and control with our proprietary tracking portal, empowering you to monitor cybersecurity risks and compliance effortlessly.
Our services go beyond compliance, addressing threats throughout the entire lifecycle of your device to protect patients and ensure reliability.
Trusted by leading manufacturers, from startups to global enterprises, to secure devices, maintain compliance, and safeguard reputations.
Partner with Blue Goat Cyber for a comprehensive postmarket solution. Schedule your free Discovery Session today.
“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