
In this episode of MDR Chats, Dr. Emily Clarke discusses the regulatory challenges and considerations for AI in medical devices. Topics include the roles involved in AI, ensuring device safety for lay users, assessing risks from imbalanced datasets and model bias, and understanding the impact of the social environment on device performance. Tune in for valuable insights on navigating the evolving regulatory landscape for AI-based medical devices. Stay tuned for an upcoming episode with a detailed analysis of the AI questionnaire!