This chapter provides a comprehensive overview of artificial intelligence (AI) and machine learning (ML) in medical device software development, as well as the AI/ML Lifecycle. It begins by introducing AI/ML-enabled medical device software, highlighting its potential to transform healthcare by deriving new insights from vast amounts of data generated during healthcare delivery. It explores how Agile Scrum methodologies can be adapted to address the unique challenges of AI/ML development in the medical device industry, enabling iterative progress and rapid response to changing requirements. The chapter then shifts focus to the regulatory landscape, providing an overview of the medical device regulatory framework. It examines the FDA’s approach to AI/ML-enabled medical devices, including the concept of Predetermined Change Control Plans (PCCPs) and the agency’s efforts to adapt its traditional paradigm to the dynamic nature of AI/ML technologies. The chapter then delves into AI/ML lifecycle management, emphasizing the importance of continuous monitoring and improvement. Security and privacy considerations are addressed, reflecting their critical importance in the healthcare sector. Finally, the chapter introduces the European Union’s AI Act, a landmark legislation with significant implications for AI/ML medical device developers. By covering these crucial aspects, the chapter equips readers with a comprehensive understanding of the complexities of developing AI/ML-enabled medical device software, emphasizing the need for a multidisciplinary approach that balances innovation with regulatory compliance.