ISO 13485 × GenAI: The Application of Generative AI in Medical Device Quality Systems

How to integrate GenAI into the ISO 13485 process tasks to establish a quality system that is controllable, verifiable, traceable, and retains human ultimate decision-making responsibility. This course will share the instructor's current research topics with QA, RA, RD, PM, and managers from small and medium-sized enterprises, focusing on 'how medical device manufacturers can compliantly integrate AI/LLM into the ISO 13485 quality management system' as a controlled co-pilot tool. Participants will receive a unique research notebook from the instructor for accessing digital learning resources after the class.