Simple solution to the medical instrumentation software problem

Robert C. Leif; Suzanne B. Leif; Stephanie H. Leif; E. Bingue

doi:10.1117/12.206023

3 April 1995 Simple solution to the medical instrumentation software problem

Robert C. Leif, Suzanne B. Leif, Stephanie H. Leif, E. Bingue

Proceedings Volume 2386, Ultrasensitive Instrumentation for DNA Sequencing and Biochemical Diagnostics; (1995) https://doi.org/10.1117/12.206023
Event: Photonics West '95, 1995, San Jose, CA, United States

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.

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Robert C. Leif, Suzanne B. Leif, Stephanie H. Leif, and E. Bingue "Simple solution to the medical instrumentation software problem", Proc. SPIE 2386, Ultrasensitive Instrumentation for DNA Sequencing and Biochemical Diagnostics, (3 April 1995); https://doi.org/10.1117/12.206023

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