April 25, 2024
Utilizing Effective Cybersecurity Risk Management as an Element of a Complete Risk Management Program
Digital Health Track
Recent legislation, guidance, and standards have added terms such as software bill of materials (SBOM), threat model, and vulnerability assessment to the collective vocabulary of connected medical device firms, their customers, and patients. This session will provide important clarity on the importance and function of these tools and related premarket and postmarket activities as components of a rigorous risk management program.
Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP
Edison Alvarez, Senior Director, Regulatory Strategic Planning for Cybersecurity, BD
Matt Hazelett, Cybersecurity Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA