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Session 3: Navigating the AI Frontier in MedTech: From SaMD to AI-Driven Drug Development
Session Chair(s)
Sridevi Nagarajan, PHD
DIA Communities Chair for AI in Healthcare
Ayusarogya, United Kingdom
Session Focus: The global MedTech environment for medical AI has reached a decisive turning point. Topics addressed include SaMD classification under the EU AI Act and FDA guidance; AI applications in drug development and MedTech innovation; validation and lifecycle control for adaptive algorithms; cybersecurity obligations; post-market surveillance; and a multi-jurisdictional regulatory strategy spanning the FDA, EMA, MHRA, and CDSCO. A panel discussion covering the future of AI in MedTech and what it means for India.
Speaker(s)
The Regulatory Landscape in 2026
Sridevi Nagarajan, PHD
Ayusarogya, United Kingdom
DIA Communities Chair for AI in Healthcare
AI in Drug Development & MedTech Innovation
Adarsh Srivastav
Roche, India
Validation, Cybersecurity & Lifecycle Control
Jaydeep Ruparelia
Infopercept, India
Founder and CEO
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