Abstract：As a non-materialized software program, software as a medical device (SaMD) is obviously different from ordinary medical
devices in quality management. This study focused on the scientific management of SaMD, with discussing the characteristics of SaMD
manufacture and the difficulties in the quality management process. Comparing the standards of ISO 13485, IEC 62304 and IMDRF/SaMD
WG/N23, etc, we made several suggestions for establishing the quality management system for SaMD.
胡凯，杨辉，沈亦红，张丹. 独立医疗器械软件的质量管理体系的思考建议[J]. 中国医疗设备, 2019, 34(9): 153-156.
HU Kai, YANG Hui, SHEN Yihong, ZHANG Dan. Suggestions for the Quality Management System of Independent Medical Device Software. China Medical Devices, 2019, 34(9): 153-156.