ABOUT US

The Zhongguancun Shuimu Medical Technology Service Group was established in 2017 and is headquartered in the Beijing Yizhuang Economic and Technological Development Zone. It is committed to accelerating the process of registration and listing of innovative medical device products, and solving the "last mile" problem of industrialization for innovative medical device companies. The Group is the chairman unit of the Clinical Trial Branch of the China Association for Medical Devices Industry, the executive vice chairman unit of the Application Evaluation Branch of the China Medical Equipment Association, and the chairman unit of the Medical Device Committee of the Beijing Pharmaceutical Association.

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Shumuk University

号外!号外!首期医疗软件检测及研发精讲系列课程开讲啦!

2022-12-06 14:22:47source | 网络




首期课程:软件需求规格说明书

首期课程直播时间:2022年12月6日16:00-17:00

直播渠道:#腾讯会议:538-244-404


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  软件需求规格说明书介绍:

软件需求分析是软件设计开发过程阶段的其中一环,软件需求规格说明书决定了后续绝大部分注册提交文档和体系文档的编制,包括设计规格、验证确认、可追溯性、互操作性、风险管理等。

本次课程主要从软件需求规格说明书的作用、编写要求、如何编制、与其他文档关系以及其中的特例和技巧等方面来系统的介绍软件需求规格说明书。通过本次课程,使软件研发工程师能更好的输出软件需求规格书及研发文档,保证医用软件的设计研发符合医疗器械相关法规和标准要求,最终保证医疗软件的安全有效性。



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