Producing quality software according to medical regulations for devices

Author

Leif, Suzanne B. ; Leif, Robert C.

Author_Institution

Coulter Corp., Hialeah, FL, USA

fYear

1992

fDate

14-17 Jun 1992

Firstpage

265

Lastpage

272

Abstract

The US Food and Drug Administration and the European Community, through EC Directives, are requiring good manufacturing standards to be applied to the software development process. The creation of software is no longer to be treated as an art form, but as an engineering process. Previous descriptions of this process, as described by US MIL-STD 2167A or the IEEE guidelines, are applicable to the software development process for medical instruments. A brief description of this methodology is given, and the suitability of the Department of Defense methodology, including the Ada programming language, for developing medical device software is discussed

Keywords

Ada; biomedical equipment; computerised instrumentation; medical computing; software quality; standards; Ada programming language; Department of Defense methodology; EC Directives; IEEE guidelines; US Food and Drug Administration; US MIL-STD 2167A; manufacturing standards; medical device software; medical instruments; medical regulations; software development process; software quality; Art; Biomedical engineering; Drugs; Food manufacturing; Guidelines; Manufacturing processes; Programming; Software quality; Software standards; Standards development;

fLanguage

English

Publisher

ieee

Conference_Titel

Computer-Based Medical Systems, 1992. Proceedings., Fifth Annual IEEE Symposium on

Conference_Location

Durham, NC

Print_ISBN

0-8186-2742-5

Type

conf

DOI

10.1109/CBMS.1992.244939

Filename

244939