AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance.

Abstract

AI-enabled cardiovascular devices are increasingly used in imaging, physiological signal analysis, and clinical decision support systems. Despite growing clinical adoption, requirements for evidence generation, software change management, and post-deployment assurance remain fragmented across jurisdictions and are often difficult to translate into operational processes within healthcare organizations. This review synthesizes common foundations of software as a medical device (SaMD) oversight and