Abstract
AbstractThere is increasing demand for effective software process assessment and improvement in the medical device industry. This is due to the expanding and complex role that software now plays in the operation and functionality of medical devices. This paper outlines the development and current status of Medi SPICE a software process assessment and improvement model which is being developed to meet the specific requirements of this safety-critical domain. This includes the selection of the most appropriate software process improvement model on which to base Medi SPICE. Its initial development and restructuring to conform to ISO/IEC 15504-5:2012 and ISO/IEC 12207:2008. The structure and content of its process reference model is outlined and an industry based trial assessment of 11 of its processes is discussed. Current and future work is considered including the timeframe for the release of a full version of the Medi SPICE model.KeywordsMedical Device SoftwareSoftware Process ImprovementSPIISO/IEC 15504-5:2012SPICEISO/IEC12207:2008IEC 62304:2006
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