Wednesday, May 7, 2025

3:40 PM - 4:25 PM

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Details

Integrating Artificial Intelligence and Machine Learning (AI/ML) in a highly regulated medical device, requires a meticulous approach. International regulators expect medical innovation to meet the highest standards of safety and effectiveness. AI/ML innovators must ensure that comprehensive product design dossiers are prepared in support of pre-market applications and on-going product commercialisation. This session will address the unique challenges of integrating AI/ML technologies within products that have traditionally been governed by strict regulatory frameworks. We will focus on essential technical areas, share about best product development practices, including how to document performance data and algorithms. The session will cover the key technical requirements for AI/ML in medical devices, demystify key guidelines from major Regulators such as FDA, IMDRF and TFA and share best practices for aligning design & manufacturing processes with regulatory expectations. We will also discuss the unique lifecycle challenges that inherently come with these products, sharing insights for control plans to ensure consistent performance of both supervised and autonomous AI/ML systems, as products continue to evolve over time.

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Speaker