Title :
A software requirements specification document model for the medical device industry
Author :
Halvorsen, Janis V. ; Khajenoori, Soheil
Author_Institution :
Food & Drug Admin., Atlanta, GA, USA
Firstpage :
0.666666666666667
Abstract :
A model of a requirements specification document for use by the medical device industry is discussed. This model combines the ANSI/IEEE and Fairley (1985) models and is designed to meet the regulatory requirements of the Food and Drug Administration. The model is not endorsed by the Food and Drug Administration nor proposed as the only model that could be used to meet the regulatory requirements. The model can also be used to analyze existing software requirements specifications documents
Keywords :
ANSI standards; IEEE standards; biomedical equipment; formal specification; industries; legislation; software standards; system documentation; ANSI model; Fairley model; Food and Drug Administration; IEEE model; medical device industry; regulatory requirements; software requirements specification document model; Computer industry; Control systems; Documentation; Drugs; Electrical equipment industry; Hardware; Medical control systems; Software maintenance; Software systems; Software testing;
Conference_Titel :
Southeastcon '93, Proceedings., IEEE
Conference_Location :
Charlotte, NC
Print_ISBN :
0-7803-1257-0
DOI :
10.1109/SECON.1993.465746
