CARDIO-AI-CHECK: CARDIO-AI: Compliance and AI Regulation for Deep Learning in ECG and Cardiac Signal Interpretation – AI – Checklist for Holistic ECG Compliance and Knowledge

CARDIO-AI-CHECK is a comprehensive checklist for developers and researchers developing cardiac AI devices, especially ECG-based ones, to meet both clinical and market requirements. It covers critical aspects of the product lifecycle from data collection, validation, model development, robustness testing to meet regulatory standards on SaMD, EU MDR, and standards lifecycle management. Beyond pre-market readiness, it also emphasizes post-market quality management systems (QMS), risk control, and continuous improvement, offering a structured pathway for secure, effective, and future-proof deployment of cardiac AI technologies.