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Medi SPICE and the development of a process reference model for inclusion in IEC 62304
Casey, Valentine; Mc Caffery, Fergal
The demand for medical device software continues to grow and there is an associated increase in its importance and complexity. This paper discusses medical device software process assessment and improvement. It outlines Medi SPICE, a software process assessment and improvement model which is being developed to meet the specific safety-critical and regulatory requirements of the medical device domain. It also details the development of a subset of the Medi SPICE process reference model for inclusion in the next release of the IEC 62304 standard: Medical device software - Software life cycle processes. IEC 62304 is a key standard for medical device software development and is approved by many national regulatory bodies including the Food and Drug Administration in the United States and the European Union. This paper also outlines 3 lightweight software process assessment methods which have been developed in tandem with Medi SPICE. Finally the timeline for the release of the full Medi SPICE model is provided.
Keyword(s): medical device software; software development; software process assessment; software process improvement; Medi Spice; IEC 62304
Publication Date:
Type: Conference item
Peer-Reviewed: Yes
Language(s): English
Institution: University of Limerick
Funder(s): Science Foundation Ireland
Citation(s): ICSOFT 2012 the 7th International Conference on Software Paradigm Trends;
First Indexed: 2014-09-25 05:37:18 Last Updated: 2019-09-19 06:27:25