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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)
Sridevi Nagarajan, PHD
DIA Communities Chair for AI in Healthcare, Ayusarogya, United Kingdom
The Regulatory Landscape in 2026
Adarsh Srivastav
Head of IVD Data Insights , Roche Diagnostics, India
AI in Drug Development & MedTech Innovation
Aseem Sahu
Deputy Drugs Controller, CDSCO Office, India
Panel Discussion: Future of AI in MedTech
Rohit Philip
Senior Consultant, Kerala Medical Technology Consortium (KMTC), India
MiRa Jacobs
Head of Digital Health, MHRA, India
Vivek Ahuja, MD
Program Chair, Executive Vice President, Pharmacovigilance, EVERSANA, India
Alberto Ganan Jimenez, PHD
Head of Committees and Quality Assurance, European Medicines Agency, Netherlands
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