人工智能医疗器械企业质量管理现状调研  

Research on Current Situation of Quality Management of Artificial Intelligence Medical Device Enterprises

作　　者：刘毅 王浩[3] 李澍[3] 张威 樊瑜波[1,5,6] LIU Yi;WANG Hao;LI Shu;ZHANG Wei;FAN Yubo(School of Biological Science and Medical Engineering,Beihang University,Beijing,100191;Beijing Beiling Special Purpose Vehicle Co.Ltd.,Beijing,101500;Institute for Medical Devices Control,National Institutes for Food and Drug Control,Beijing,102629;China National Medical Device Co.Ltd.,Beijing 100028;Beijing Advanced Innovation Centre for Biomedical Engineering,Key Laboratory for Biomechanics and Mechanobiology of Chinese Education Ministry,Beijing,100191;School of Engineering Medicine,Beihang University,Beijing,100191)

机构地区：[1]北京航空航天大学生物与医学工程学院,北京市100191 [2]北京北铃专用汽车有限公司,北京市101500 [3]中国食品药品检定研究院医疗器械检定所,北京市102629 [4]中国医疗器械有限公司,北京市100028 [5]北京航空航天大学生物医学工程高精尖创新中心生物力学与力学生物学教育部重点实验室,北京市100191 [6]北京航空航天大学医学科学与工程学院,北京市100191

出　　处：《中国医疗器械杂志》2021年第2期194-199,共6页Chinese Journal of Medical Instrumentation

基　　金：国家重点研发计划(2020YFC2007104)。

摘　　要：目的了解人工智能生产企业质量管理现状,为人工智能医疗器械(Artificial Intelligence Medical Device,AIMD)产品质量管理研究与标准化提供参考依据。方法基于YY/T 0287-2017《医疗器械质量管理体系用于法规的要求》、《医疗器械生产质量管理规范独立软件附录》和《Xavier GMLP报告》,通过专家咨询法和文献查阅结合的方法筛选相应的要素并设计调研问卷;然后定向邀请32家具有代表性的AIMD企业进行问卷的填写;数据结果利用Excel 2016进行描述性统计分析。结果通过对调研结果中的产品策划和设计、结果输出、产品质控和产品变更4个主题进行深度分析发现,参与调研的企业均有必要在不同程度上对其AIMD产品的质量管理体系进行完善。结论此研究为首次系统地对AIMD企业的质量管理现状进行调研,其结果可以为企业内部建立和完善产品质量管理体系提供建议,为AIMD产品质量管理研究与标准的建立提供参考依据。Objective To understand the current situation of artificial intelligence production enterprise quality management system,so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device(AIMD)product quality management.Methods Based on YY/T 0287-2017 Medical Device Quality Management System for Regulatory Requirements,Medical Equipment Production and the Quality Control Standard for Independent Software Appendix and Xavier GMLP report,the relevant factors were screened and the questionnaire was designed by combining expert consultation and literature review.Then,a total of 32 representative AIMD enterprises were invited to fill in the questionnaire.Descriptive statistical analysis was performed on the data results using Excel 2016.Results Through in-depth analysis of the four themes in product planning and design,result output,product quality control and product change,it was found that it was necessary for enterprises participating in the survey to improve the quality management system of AIMD products to different degrees.Conclusion This study is the first time to systematically investigate the status quo of quality management of AIMD enterprises.The result will be useful for the establishment and continuous improvement of product quality management system.It will also provide a reference for the research of AIMD product quality management and the establishment of the standard.

关 键 词：人工智能 人工智能医疗器械 产品质量管理体系 辅助诊断 健康管理 

分 类 号：TP391.4[自动化与计算机技术—计算机应用技术] TH772[自动化与计算机技术—计算机科学与技术]