Cybellum Launches Omnibus Preparedness Accelerator Program to Assist Medical Device Manufacturers with Expanded FDA Cybersecurity Regulations

Helps medical device manufacturers to ensure cybersecurity compliance with SBOM and Vulnerability Management requirements as detailed in the 2023 Omnibus Appropriations Bill

TAMPA, Fla., May 10, 2023 /PRNewswire/ -- Cybellum, creators of the Product Security Platform, announced today at the H-ISAC Spring Summit, the launch of its Omnibus Preparedness Accelerator Program. This will help medical device manufacturers comply with the recently expanded regulations from the US Food and Drug Administration (FDA) for Software Bill of Materials (SBOM) and Vulnerability Management.

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," said David Leichner, CMO of Cybellum. "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," said Leichner.

The Omnibus Preparedness Accelerator Program is available immediately and interested parties can contact Cybellum here for more information.

About Cybellum

Cybellum is where teams do product security.

Top ten medical device manufacturers use Cybellum's Product Security Platform to execute and manage the main aspects of their cybersecurity operations across teams, product lines, and business units. From SBOM to Vulnerability Management, Compliance Validation, and Incident Response, teams ensure their connected products are fundamentally secure and compliant – and stay that way.

Powered by Cyber Digital Twins™ technology, Cybellum creates a live digital replica of every software component inside the devices, allowing product security teams to manage cyber risk continuously.

To learn more visit www.cybellum.com

Media Contact:
Annette Habani
Marketing Manager
[email protected]

SOURCE Cybellum