Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304

Valentine Casey, Fergal Mc Caffery

Abstract

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.

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Paper Citation


in Harvard Style

Casey V. and Mc Caffery F. (2012). Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304 . In Proceedings of the 7th International Conference on Software Paradigm Trends - Volume 1: ICSOFT, ISBN 978-989-8565-19-8, pages 237-246. DOI: 10.5220/0004082102370246


in Bibtex Style

@conference{icsoft12,
author={Valentine Casey and Fergal Mc Caffery},
title={Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304},
booktitle={Proceedings of the 7th International Conference on Software Paradigm Trends - Volume 1: ICSOFT,},
year={2012},
pages={237-246},
publisher={SciTePress},
organization={INSTICC},
doi={10.5220/0004082102370246},
isbn={978-989-8565-19-8},
}


in EndNote Style

TY - CONF
JO - Proceedings of the 7th International Conference on Software Paradigm Trends - Volume 1: ICSOFT,
TI - Medi SPICE and the Development of a Process Reference Model for Inclusion in IEC 62304
SN - 978-989-8565-19-8
AU - Casey V.
AU - Mc Caffery F.
PY - 2012
SP - 237
EP - 246
DO - 10.5220/0004082102370246