人工智能医学软件产品现场检查要点研究

Research on key points of on-site inspection of artificial intelligence medical software products

目的本文通过厘清AI医学软件现场检查要点与《医疗器械生产质量管理规范独立软件现场指导原则》(以下简称《指导原则》)之间的关系,归纳和分析AI医学软件现场检查的特殊要求并提供部分建议。方法基于广东省药品监督管理局审评认证中心非公开数据库,比对《指导原则》自2020年7月1日施行后至2021年12月31日期间通过医疗器械质量体系核查的33家生产企业AI医学软件产品现场检查情况,研究AI医学软件生产企业相关产品的研发、生产工艺、经营管理等方面的问题,分析AI医学软件产品需要注重细化的检查环节。结果针对现场检查情况,本文总结了企业质量体系检查的共性问题,细化了AI医学软件特殊要求。结论本研究从人员、设计开发、采购、不良事件监测分析和改进四个方面为AI医学软件现场检查的特殊要求提出建议,为我国AI医学软件产品的质量管理体系检查工作提供借鉴。

Objective This paper will clarify the relationship between the main points of AI medical software on-site inspection and the Guidelines for the on-site inspection of independent software for medical device production quality management specification[2](hereinafter referred to as the Guidelines),summarize and analyze the special requirements of AI medical software on-site inspection and provide some suggestions.Methods Based on the non-public database of Center for Certification and Evaluation,Guangdong Drug Administration,compared to the Guiding Principles On-site inspection situation,the AI medical software products of 33 manufacturers who passed the medical device quality system verification from July 1,2020 to December 31,2021 after the implementation of the Guiding Principles On-site inspection situation were conducted to figure out the problem of the AI medical software manufacturers related to product development,production process,business management and other aspects,and the refinement of the inspection links of AI medical software products needed to focus on.Results According to the on-site inspection situation,this paper summarizes the common problems of enterprise quality system inspection,and refines the AI software special requirements.Conclusion This study puts forward suggestions for the special requirements of AI medical software on-site inspection from four aspects:personnel,design and development,procurement,adverse event monitoring,analysis and improvement,to provide reference for the quality management system inspection of AI medical software products in China.