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A Hazard Analysis for a Generic Insulin Infusion Pump

by Yi Zhang, Paul L Jones, Raoul Jetley
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Abstract

Researchers at the FDA have been exploring the concept of model-based engineering as a measn for improving the quality of medical device software. Insulin pumps were choosen as a research subject becuase their design provides the desired degree of research complexity and these types of devices present an ongoing regulatory challenge.

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