Artificial intelligence (AI) and machine learning (ML) are already altering healthcare in dramatic ways. With a dearth of regulatory requirements and guidance in the development and implementation of AI/ML in medical devices, however, manufacturers are forced to fit their state-of-the-art technologies into decades-old regulatory schemes. This session will provide attendees with usable techniques for providing objective evidence of compliance while leveraging the power of AI/ML to improve the safety and effectiveness of your medical devices.