The growing use of wireless orthopedic devices, the electronic exchange of device-related health information and increases in the volume and scope of recent cyberattacks in the healthcare sector have ramped up FDA’s focus on protecting the safety and functionality of medical devices. The latest draft guidance issued by the agency provides recommendations to incorporate cybersecurity risk-mitigating measures across the entire quality system. Experts share ways to build foundational cybersecurity processes in device design, premarket submission documentation and quality systems. They’ll also share how to adapt to FDA’s rapidly evolving approach to maintaining cybersecurity in device development.
Learning Objectives:
• Understand how to implement the key recommendations in FDA’s draft guidance
• Grasp the importance of a comprehensive cybersecurity risk management program
• Learn how to integrate cybersecurity early in the device lifecycle and across the quality system
