Software Development Practice for FDA-Compliant Medical Devices

摘要：

Software development in medical devices by implementing lightweight processes in formal regulatory environments is an issue. This paper describes software development practice with the project of Digital Subtraction Angiography (DSA) medical device, and introduces experiences to ensure FDA regulatory compliance In addition, we introduce a hybrid methodology adopted in our software development process which is to use agile method to reduce project risk, and use formal waterfall-like lifecycle to create documents.

作者: Weiguo Lin Xiaomin Fan

作者单位: College of Computing, Communication University of China Beijing Wandong Medical Equipments Corp.

会议类型: 国际会议

会议名称: The Second International Joint Conference on Computational Science and Optimization(CSO 2009)(2009 国际计算科学与优化会议)

会议地点: 三亚

会议语种:英文

页码: 1438-1440

在线出版日期: 2009-04-24（万方平台首次上网日期，不代表论文的发表时间）