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 d...Show MoreMetadata
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.<>
Published in: Proceedings of Southeastcon '93
Date of Conference: 04-07 April 1993
Date Added to IEEE Xplore: 06 August 2002
Print ISBN:0-7803-1257-0