Software Development Practice for FDA-Compliant Medical Devices

Author

Lin, Weiguo ; Fan, Xiaomin

Author_Institution

Coll. of Comput., Commun. Univ. of China, Beijing, China

Volume

2

fYear

2009

fDate

24-26 April 2009

Firstpage

388

Lastpage

390

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;

fLanguage

English

Publisher

ieee

Conference_Titel

Computational Sciences and Optimization, 2009. CSO 2009. International Joint Conference on

Conference_Location

Sanya, Hainan

Print_ISBN

978-0-7695-3605-7

Type

conf

DOI

10.1109/CSO.2009.191

Filename

5193978