Medical Device Safety Throughout the Product Lifecycle: Regulatory Frameworks, Digital Transformation, and the Role of Artificial Intelligence in Devices and Monitoring.

Abstract

Medical devices are a mainstay in modern healthcare, supporting the diagnosis, monitoring, treatment, and management of acute and chronic conditions. Rapid technological innovation, increasing software dependence, growing connectivity, and the emergence of artificial intelligence (AI)-enabled systems have expanded the traditional boundaries of device safety. This narrative review examines medical device safety across the product lifecycle, from early design and preclinical development through cl