摘要
独立医疗器械软件作为一种非实体化的软件程序,在进行质量管理时和普通医疗器械差异较大。本文以科学管理独立医疗器械为出发点,讨论了独立医疗器械软件生产特点及质量管理过程中的难点,参照ISO 13485、IEC 62304、IMDRF/SaMD WG/N23等标准,对比了标准间的差异并提出了相应的建议,作为对建立独立医疗器械软件的质量管理体系的思考。
As a non-materialized software program,software as a medical device(SaMD)is obviously different from ordinary medical devices in quality management.This study focused on the scientific management of SaMD,with discussing the characteristics of SaMD manufacture and the difficulties in the quality management process.Comparing the standards of ISO 13485,IEC 62304 and IMDRF/SaMD WG/N23,etc,we made several suggestions for establishing the quality management system for SaMD.
作者
胡凯
杨辉
沈亦红
张丹
HU Kai;YANG Hui;SHEN Yihong;ZHANG Dan(Department of Evaluation,Medical Device Evaluation Center of Zhejiang,Hangzhou Zhejiang 311121,China)
出处
《中国医疗设备》
2019年第9期153-156,共4页
China Medical Devices
关键词
医疗器械软件
质量管理体系
医疗领域信息化
medical device software
quality management system
medical field informatization
