This chapter provides a comprehensive examination of the latest regulatory developments in AI Lifecycle Frameworks for the medical device industry. It begins with initiatives by the US Food and Drug Administration and Health Canada aimed at addressing and simplifying regulatory hurdles in the development of artificial intelligence software for medical devices. The FDA’s recent draft guidance on AI-enabled device software functions offers detailed recommendations for lifecycle management and marketing submissions. Health Canada’s guidance on machine learning-enabled medical devices, which covers topics such as bias, data representativeness, and transparency, is discussed. The chapter explores state-of-the-art practices for AI software development, emphasizing the importance of a total product lifecycle approach. The discussion then shifts to the European Union’s AI Act, which introduces a risk-based approach to regulating AI systems, categorizing them into four risk levels: unacceptable, high, limited, and minimal. It also explores AI-enabled medical device risk management, emphasizing the crucial role of usability engineering in the development of these devices. The discussion underscores the importance of minimizing use-related hazards and risks, ensuring that users can operate devices safely and effectively. By examining these regulatory frameworks and best practices, the chapter provides valuable insights into the complex landscape of AI regulation and development in the medical device industry.