SPEAKER: Attrayee (Atty) Chakraborty MS, MSc., CQSP
AI in 2025: where and how does it fit in a medical device product development life cycle?
The increasing integration of Artificial Intelligence (AI) in medical devices, evidenced by around 1000 AI-enabled medical devices cleared by the FDA, underscores the need for clear and comprehensive quality and regulatory requirements. As we move into 2025, the burning question is: how do we successfully integrate AI into a medical device? At which stages do we perform testing? And at which stages do we think of planning, development and deployment? This session aims to help understand these aspects along with the FDA's draft guidance on AI-enabled medical devices.
Participants will gain an understanding of product, regulatory and key quality considerations that need to be addressed, for an AI-enabled medical device.
Participants will understand how to build effective products using:
- Risk management principles
- Clinical validation
- Design controls.
Speakers:
Attrayee (Atty) Chakraborty MS, MSc., CQSP is a Quality Systems Specialist at Analog Devices. a global semiconductor company with roots in digital healthcare. With a background in working with medical device startups and Fortune 500 companies in India and the U.S., she is committed to quality improvement in the healthcare space. She is also a working member of AI Global Health Initiative (AIGHI) AI in Operations team and IEEE P3396 for Recommended Practice for Defining and Evaluating Artificial Intelligence (AI) Risk, Safety, Trustworthiness, and Responsibility, and is an AI Community Leader at RAPS. Atty has presented at numerous national and international conferences and been featured in several articles on AI.
Dr. Mandar Karhade is the Chief AI Officer at Quench, a Medical Legal Startup. His cumulative experience spans over 16 years in healthcare technology and data science, with his previous role as Senior Director of AI/ML at Avalere Health. He holds an MD, a PhD in Epidemiology, and an MPH. Mandar is the founder and CEO of Citingale, developing SaaS solutions for AI-driven life sciences research and consulting life sciences and health technology partners. His cross-functional background from medical expertise, technology, public health, and AI/ML makes him uniquely qualified to translate regulatory guidance into practical requirements. As a prolific researcher, Mandar has published extensively in peer-reviewed journals, spoken at various conferences, and has held workshops about AI, AI in healthcare, and AI in Medical Devices.
The event is free of charge but requires registration. Please click the link or scan the QR code to register. You will receive a confirmation with a link to the meeting. You will receive 0.1 RU for attendance.