Abstract：Objective To study the development trend of quality management of artificial intelligence (AI) and promote the research
of standards and specifications. Methods The special issues faced by quality management of AI medical devices were summarized
according to the latest AI medical devices related regulations. The demand and development direction of quality management of AI
medical devices were analyzed in combination with the practice of product testing. Results In the process of quality management of
AI medical devices, traceability, data set management, quality control and other aspects need to be further enhanced.
Conclusion The ideas and methods of this paper are helpful to establish the special standards for AI medical devices.
王浩，李澍，王晨希，唐桥虹，李佳戈，李静莉. 人工智能医疗器械质量管理标准化趋势分析[J]. 中国医疗设备, 2021, 36(3): 20-23.
WANG Hao, LI Shu, WANG Chenxi, TANG Qiaohong, LI Jiage, LI Jingli. Trend Analysis of Quality Management Standardization of Artificial
Intelligence Medical Devices. China Medical Devices, 2021, 36(3): 20-23.
