Title :
Producing quality software according to medical regulations for devices
Author :
Leif, Suzanne B. ; Leif, Robert C.
Author_Institution :
Coulter Corp., Hialeah, FL, USA
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;
Conference_Titel :
Computer-Based Medical Systems, 1992. Proceedings., Fifth Annual IEEE Symposium on
Conference_Location :
Durham, NC
Print_ISBN :
0-8186-2742-5
DOI :
10.1109/CBMS.1992.244939
