Cybellum has introduced the Omnibus Preparedness Accelerator Program, aimed at aiding medical device manufacturers in meeting the updated regulations set by the U.S. FDA regarding Software Bill of Materials (SBOM) and Vulnerability Management. This program will assist manufacturers in complying with these expanded regulations.

As part of the FDA’s efforts to improve the cybersecurity of medical devices, the agency has issued updated guidance on SBOM and vulnerability management, requiring manufacturers to provide a list of all software and components used in their products and maintain a vulnerability management program to mitigate security risks. 

To help medical device manufacturers meet these requirements, Cybellum has developed the Omnibus Preparedness Accelerator Program, a comprehensive solution that provides guidance, tools, and services to streamline the SBOM and vulnerability management processes.

“We understand the challenges that medical device manufacturers face in complying with the FDA’s new regulations,” says David Leichner, Cybellum’s chief marketing officer. “Our Omnibus Preparedness Accelerator Program is designed to simplify the process and help manufacturers improve their cybersecurity posture.”

The Omnibus Preparedness Accelerator Program includes the following key components:

  • Discovery and planning: Working with medical device manufacturers to assess compliance readiness based on their current setup, identified gaps, and defining the main processes and tools needed to comply.
  • SBOM management: Providing a comprehensive inventory of all software components used in a medical device, enabling manufacturers to easily generate an SBOM report that meets the FDA’s requirements.
  • Vulnerability management: Enables continuous monitoring of the medical device’s software components and alerts manufacturers to any vulnerabilities that are discovered, enabling them to take action to mitigate the risk.

In addition to these key components, the Omnibus Preparedness Accelerator Program includes access to Cybellum’s team of cybersecurity experts, who can provide guidance and support throughout the SBOM and vulnerability management process, for planning and integrating new regulatory requirements into existing workflows.

“By providing a comprehensive solution that covers all aspects of the SBOM and vulnerability management process, we’re helping medical device manufacturers to reduce their cybersecurity risks and comply with the FDA’s expanded regulations,” says Leichner.