摘要
目的旨在研究人工智能(Artificial Intelligence,AI)医疗器械质量管理的发展趋势,促进标准规范研究。方法根据AI医疗器械相关监管、法规的最新动态,梳理质量管理面临的特殊问题;结合产品检测实践情况,分析AI医疗器械质量管理的需求与发展方向。结果在AI医疗器械的质量管理过程中,可溯源性、数据集管理、质量控制等方面都需进一步增强。结论本文研究的思路和方法有助于建立适合AI医疗器械的专用标准规范。
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.
作者
王浩
李澍
王晨希
唐桥虹
李佳戈
李静莉
WANG Hao;LI Shu;WANG Chenxi;TANG Qiaohong;LI Jiage;LI Jingli(Institute for Medical Device Control,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国医疗设备》
2021年第3期20-23,共4页
China Medical Devices
基金
国家重点研发计划课题(2019YFC0118801)。
关键词
人工智能医疗器械
质量管理
溯源
质量控制
artificial intelligence medical devices
quality management
traceability
quality control
