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.