Accessing the capital-rich, innovation-friendly US digital health market remains a key priority for healthtech executives the world over - but to achieve success, it is essential for companies to understand and plan for the US market's complex and evolving regulatory environment.
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In this session, experts from MCRA, Nicole Batista Jason Tugman, will explore and reveal best practices for entering the US market and strategies to thrive in its changing regulatory landscape.
What we will cover:
- Digital Health Market Growth & Future Potential
- Regulatory Considerations & Evolving Landscape
- Understanding When Regulatory Requirements are Applicable
- Risk Management & Cybersecurity
Nicole Batista, Associate Director, Cardiovascular Regulatory Affairs, MCRAFormer FDA Assistant Director in the Division of Cardiac Electrophysiology, Diagnostics, & Monitoring Devices
Extensive knowledge of digital health medical device regulations and policies
Additional prior roles at FDA include Senior Lead Reviewer, Peripheral Intervention
Devices Team and Lead Reviewer, Interventional Cardiology Devices Branch
Jason Tugman, Associate Director, Cybersecurity Risk Management & Strategy, MCRA15+ years of Cybersecurity experience with a medical and digital health focus
Extensive experience within multiple frameworks (NIST, ISO, etc.), expertise in FDA Pre-market & Post-market Medical Device Joint Security Plan (JSP)
An active industry speaker and leader of talks regarding FDA cybersecurity in medical devices