摘要
目的人工智能医疗器械产品更新频率远高于传统医疗器械,因此需要建立动态稳健的医疗器械质量管理体系新模式,促进人工智能医疗器械产品健康发展。方法通过讨论人工智能医疗器械的质量管理体系框架,在此基础上,讨论了影响人工智能医疗器械质量的关键因素,设计变更和验证确认环节的控制思路。并对人工智能医疗器械在质量评价过程中需重点关注的内容进行了比较全面的讨论,包括软件可解释性、评价方法和验证及确认方法问题。结果影响人工智能医疗器械质量的关键因素包括设计变更和验证确认环节。同时,软件可解释性、评价方法和验证及确认也需要进行重点关注。结论人工智能医疗器械正处于蓬勃发展期,相应的技术和业态也在不断形成中,需要针对人工智能医疗器械企业需要建立动态稳健的质量管理新模式,在缩短产品迭代更新的研发与验证周期的同时,及时前瞻性地发现算法更新带来的质量风险。
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.
作者
李澍
王浩
王晨希
郝烨
李佳戈
李静莉
LI Shu;WANG Hao;WANG Chenxi;HAO Ye;LI Jiage;LI Jingli(Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国医疗设备》
2021年第9期15-18,22,共5页
China Medical Devices
基金
国家重点研发计划(2019YFC1711702)。
关键词
人工智能
医疗器械
质量管理体系
机器学习
可解释性
artificial intelligence
medical devices
quality management system
machine learning
interpretability
