This course explores testing strategies and study design considerations for diagnostic AI models requiring premarket clearance by regulatory bodies like the USA FDA, EU MDR, and those adhering to ISO 13485 standards. Focusing on detection AI, the training covers bench and clinical testing, emphasizing their roles in bias mitigation, clinical effectiveness, and regulatory compliance.

This course offers a comprehensive overview of Quality Management System (QMS) considerations essential for the development and regulatory approval of diagnostic AI models classified as medical devices. It is specifically tailored for AI models requiring premarket clearance by the U.S. FDA, EU MDR, and other regulatory bodies that mandate adherence to ISO 13485 standards. 

This webinar features an insightful discussion between a technical specialist, Bob, and a clinical specialist, Jeannine, focusing on the various factors that influence the accuracy of infusion pumps. The session will highlight the importance of the new TIR101 testing, which provides crucial data to help healthcare professionals make informed decisions at the bedside.

This course offers a concise overview of Human Factors (HF) in medical device design, focusing on its integration across all stages of product development, from concept to post-market surveillance (PMS).

People involved with designing and implementing production processes are often challenged with how to characterize their product or processes and, then, optimize results. This is especially true for medical device and pharmaceutical firms. What parameters are key to quality? How do we quickly and efficiently identify these parameters and decide on strategies to optimize quality? This webinar is focused on a “Faster, Better, Cheaper” methodology.