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Proceedings Paper

Simple solution to the medical instrumentation software problem
Author(s): Robert C. Leif; Suzanne B. Leif; Stephanie H. Leif; E. Bingue
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Paper Abstract

Medical devices now include a substantial software component, which is both difficult and expensive to produce and maintain. Medical software must be developed according to `Good Manufacturing Practices', GMP. Good Manufacturing Practices as specified by the FDA and ISO requires the definition and compliance to a software processes which ensures quality products by specifying a detailed method of software construction. The software process should be based on accepted standards. US Department of Defense software standards and technology can both facilitate the development and improve the quality of medical systems. We describe the advantages of employing Mil-Std-498, Software Development and Documentation, and the Ada programming language. Ada provides the very broad range of functionalities, from embedded real-time to management information systems required by many medical devices. It also includes advanced facilities for object oriented programming and software engineering.

Paper Details

Date Published: 3 April 1995
PDF: 12 pages
Proc. SPIE 2386, Ultrasensitive Instrumentation for DNA Sequencing and Biochemical Diagnostics, (3 April 1995); doi: 10.1117/12.206023
Show Author Affiliations
Robert C. Leif, Newport Instruments (United States)
Suzanne B. Leif, Newport Instruments (United States)
Stephanie H. Leif, Newport Instruments (United States)
E. Bingue, AdaSoftware Engineering Education Training Team (United States)

Published in SPIE Proceedings Vol. 2386:
Ultrasensitive Instrumentation for DNA Sequencing and Biochemical Diagnostics
Gerald E. Cohn; Jeremy M. Lerner; Kevin J. Liddane; Alexander Scheeline; Steven A. Soper, Editor(s)

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