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A hazard analysis for a generic insulin infusion pump.

by Yi Zhang, Paul L Jones, Raoul Jetley
Journal of diabetes science and technology (Online) ()
  • ISSN: 19322968 (ISSN)
  • PubMed: 20307387

Abstract

Researchers at the Food and Drug Administration (FDA)/Center for Device and Radiological Health/Office of Science and Engineering Laboratories have been exploring the concept of model-based engineering as a means for improving the quality of medical device software. Insulin pumps were chosen as a research subject because their design provides the desired degree of research complexity and these types of devices present an ongoing regulatory challenge.

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