MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 25, 2024

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10:05 am

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12:00 pm

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.

Moderator

Eric Henry, Senior Quality & Regulatory Compliance Advisor, King & Spalding LLP

Speakers

Edison Alvarez, Senior Director, Regulatory Strategic Planning for Cybersecurity, BD
Matt Hazelett, Cybersecurity Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA