This whitepaper explores the cybersecurity, safety, and regulatory challenges associated with connected medical devices, particularly in the context of FDA requirements. It explains how increasing device connectivity and software complexity introduce risks such as ransomware attacks, data breaches, and patient safety threats. The paper outlines the regulatory landscape, including FDA classification systems and premarket approval processes, and emphasizes the importance of integrating security into device design and development. It recommends adopting risk-based approaches, continuous monitoring, threat modeling, and lifecycle security practices. By aligning development with regulatory guidance and security best practices, manufacturers can ensure device safety, compliance, and trust.

Join for free to read