The evolving landscape of cybersecurity regulations for medical devices demands increased attention from OEMs, especially concerning the integration of diverse code bases and intellectual property from open-source and third-party sources. Recent changes in standards, including FDA regulations and the EU Cyber Resilience Act, have highlighted the need for robust cybersecurity measures and accurate reporting of vulnerabilities. Current supply chain management processes often fall short in meeting these rigorous demands, leading to discrepancies in software supply security across the industry.

VDC Research’s latest whitepaper delves into these challenges, offering insights into how OEMs can achieve a trusted supply chain and ensure compliance. The whitepaper outlines essential processes and functionalities that manufacturers must adopt, such as real-time vulnerability reporting, timely updates and patches, and comprehensive documentation, including Software Bill of Materials (SBOMs).

The paper also explores practical solutions that simplify compliance, like Toradex’s Torizon, an open-source industrial Linux distribution. By adopting these measures, medical device manufacturers can better navigate the complexities of emerging cybersecurity regulations and safeguard their products effectively.