This research paper explores the application of Agile methodologies in the highly regulated field of medical device software development. As the healthcare industry continues to evolve rapidly, there is an increasing need for efficient and flexible software development processes that can meet stringent regulatory requirements while delivering high-quality, innovative medical device software. This study examines the challenges of implementing Agile practices in a regulated environment, proposes strategies for adapting Agile methodologies to meet regulatory standards, and presents case studies of successful implementations. The paper also discusses best practices, potential pitfalls, and future trends in Agile medical device software development.