Abstract：Objective The update frequency of artificial intelligence (AI) medical devices is much higher than that of traditional
medical devices. Therefore, it is necessary to establish a new dynamic and stable mode of medical device quality management system
to promote the healthy development of AI medical devices. Methods By discussing the framework of quality management system of
AI medical devices, the key factors affecting the quality of AI medical devices and the control ideas of design change and validation
were discussed. In addition, the key points in the process of quality evaluation of AI medical devices were discussed comprehensively,
including software interpretability, evaluation methods, verification and validation methods. Results The key factors affecting the
quality of AI medical devices include design change and verification and validation. At the same time, software interpretability,
evaluation method, verification and validation also need to be focused on. Conclusion AI medical devices are in a period of vigorous
development, and the corresponding technologies and formats are also constantly forming. It is necessary to establish a new dynamic
and robust quality management mode for AI medical device enterprises, so as to timely and prospectively discover the quality risks
brought by algorithm update while shortening the research and development and verification cycle of product iterative update.
李澍，王浩，王晨希，郝烨，李佳戈，李静莉. 人工智能医疗器械软件生产质量管理体系特殊要求研究[J]. 中国医疗设备, 2021, 36(9): 15-18.
LI Shu, WANG Hao, WANG Chenxi, HAO Ye, LI Jiage, LI Jingli. Study on Special Requirement of Artificial Intelligence Medical Device Quality Management System. China Medical Devices, 2021, 36(9): 15-18.