Title :
Software Development Practice for FDA-Compliant Medical Devices
Author :
Lin, Weiguo ; Fan, Xiaomin
Author_Institution :
Coll. of Comput., Commun. Univ. of China, Beijing, China
Abstract :
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.
Keywords :
biomedical equipment; government policies; medical computing; radiography; software engineering; Digital Subtraction Angiography medical device; FDA-compliant medical device; Food and Drug Administration; agile method; formal regulatory environment; formal waterfall-like lifecycle; project risk reduction; software development practice; Angiography; Biomedical equipment; Biomedical imaging; Control systems; Educational institutions; Image storage; Manufacturing processes; Programming; Software safety; X-ray imaging; Medical Devices; Regulatory Compliance; Software Development Process;
Conference_Titel :
Computational Sciences and Optimization, 2009. CSO 2009. International Joint Conference on
Conference_Location :
Sanya, Hainan
Print_ISBN :
978-0-7695-3605-7
DOI :
10.1109/CSO.2009.191
