医疗软件可追溯性分析研究的技术审评与体系核查思考

Key Points of Technical Evaluation and System Verification in the Traceability Analysis of Medical Software

随着科技的不断进步和医疗领域的发展,医疗器械软件产品的功能也越来越丰富和复杂,同时也对医疗器械软件的审查提出了更高的要求。通过梳理《医疗器械软件注册审查指导原则》(2022年修订版)、《医疗器械生产质量管理规范独立软件现场检查指导原则》、《医疗器械生产质量管理规范附录独立软件》中对可追溯性分析的要求,归纳和分析医疗器械软件产品在进行可追溯性分析时的要求,并提供部分技术审评、体系核查要点和建议。最终提出了可追溯性分析的要点,以期为医疗器械软件的技术审评及体系核查时如何进行软件可追溯性分析提供参考。

With the continuous progress of technology and the development of the medical field,the functions of medical device software products are becoming increasingly rich and complex,and higher requirements are also put forward for the review of medical device software.This article summarizes and analyzes the requirements for traceability analysis in the“Guidelines for Medical Device Software Registration Review”(revised in 2022),the“Guidelines for the onsite Inspection of Independent Software Site of Medical Device Production Quality Management Specification”,and the“Appendix of Independent Software of Medical Device Production Quality Management Specification”,summarizes and analyzes the requirements for traceability analysis of medical device software products,and provides some technical review and system verification points and suggestions.The key points of traceability analysis were ultimately proposed,providing reference and inspiration for how to conduct software traceability analysis in the technical evaluation and system verification of medical device software.