Introductory paper

S. Purushothaman Iyer, David Hislop, Paul L. Jones, Jaime Lee, Frederick Pearce and Stephen Van Albert

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Abstract

The computer-assisted resuscitation algorithm (CARA) is the software component of an automatic infusion pump system being designed by US Armyrsquos Walter Reed Institute of Research (WRAIR) to be used in the battlefields of tomorrow. Such medical devices are safety critical, and their use needs to be approved by the US Food and Drug Administration (FDA) – a process on which formal methods can have a great impact. In this special section, six papers on the analysis of CARArsquos requirements are presented. In the rest of this introduction, we present the framework and summary of results from those papers.

Keywords  Software in medical devices - Safety of software - Formal methods - Analysis of requirements and designs - US Food and Drug Administration

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