What are some of the FDA regulations around cybersecurity of medical devices, and how does RunSafe fit in?

Are you a medical device manufacturer struggling to meet the FDA’s evolving cybersecurity regulations? In this video, RunSafe’s Jeff Numark breaks down FDA requirements for securing medical devices and how RunSafe Security can help you comply with these standards while protecting your devices from memory vulnerabilities.

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Stay Compliant with FDA Regulations While Strengthening Cybersecurity in Medical Devices

As the FDA increases its focus on cybersecurity for medical devices, manufacturers are under pressure to comply with new regulations that ensure device security and patient safety. The FDA’s amendments to Section 524B of the Food, Drug, and Cosmetic Act now require secure development processes and a comprehensive Software Bill of Materials (SBOM) for every device submitted for approval.

RunSafe Security helps medical device manufacturers meet these requirements with solutions designed to enhance both compliance and security. Our proprietary SBOM generation occurs at build time, providing detailed visibility into software components. Additionally, our patented memory protection technology mitigates memory-based vulnerabilities, ensuring devices are resilient against cyberattacks.

By combining RunSafe’s Identify and Protect offerings, manufacturers can streamline FDA compliance and reduce the risk of cybersecurity threats, safeguarding their devices throughout their lifecycle.

The Importance of SBOMs

The Importance of SBOMs

Apr 18, 2025

Build-Time SBOMs: Your First Line of Defense in Software Security The software you write might be secure—but what about the libraries, vendor binaries, or open-source packages you're pulling in? In this video, RunSafe Security’s CTO breaks down why build-time Software...

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