The integration of artificial intelligence (AI) in medical devices is revolutionizing healthcare, offering transformative capabilities and new challenges. This session delves into the critical aspects of developing and managing AI-enabled medical devices, focusing on regulatory compliance and quality systems.
Participants will gain insights into global regulatory requirements and the evolving positions of major regulatory bodies concerning AI in medical devices. The session will provide a comprehensive overview of risk management, design controls, and clinical evaluation considerations essential for building a robust Quality Management System (QMS) tailored to AI-enabled medical devices.
Attendees will also explore current regulatory and quality best practices and emerging standards shaping AI development and deployment in medical devices worldwide. These insights will equip professionals with the knowledge to navigate the complexities of regulatory compliance while fostering innovation.
Finally, the session will address strategies for developing and supporting AI-enabled medical devices that meet the rigorous requirements of global regulatory submissions. This proposal aims to empower professionals to integrate AI into medical devices effectively while maintaining the highest standards of quality, safety, and compliance in a rapidly evolving regulatory landscape.
Learning Objectives:
Upon completion, participants will be able to review current regulatory best practices and emerging standards shaping the development of and examine the global regulatory requirements and positions related to AI in medical devices.
Upon completion, participants will be able to understand strategies for developing and supporting AI-enabled medical devices to meet the requirements for global regulatory submissions.
Upon completion, participants will be able to explore key considerations for risk management, design controls, and clinical evaluation when building a Quality Management System (QMS) for AI-enabled medical devices.
