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Understanding the Relationships Within the Medi SPICE Framework

Authors:
Derek Flood
Fergal Mc Caffery
Valentine Casey

Keywords: Software Process; Medical Device Regulation; Software Process Improvement Roadmaps.

Abstract:
Regulated domains, such as medical device software development, require organisations to have specific processes in place in order to secure regulatory approval. Software process improvement initiatives, such as Medi SPICE, help organisations to improve their process in conformance with these regulations. These initiatives, however, do not specify how an organisation implements these processes, instead detailing what the organisation must implement. This work proposes the development of a series of roadmaps that will guide an organisation through the implementation of the required processes in a regulatory compliant manner. This paper presents the first step towards achieving this aim, which involves an investigation of the dependencies between the base practices defined in Medi SPICE in order to ensure that the produced roadmaps form a complete software development process in line with regulatory requirements. The paper describes two complementary approaches, a structured representation and a graphical representation, to representing the links between practices in the Medi SPICE framework.

Pages: 254 to 259

Copyright: Copyright (c) IARIA, 2012

Publication date: November 18, 2012

Published in: conference

ISSN: 2308-4235

ISBN: 978-1-61208-230-1

Location: Lisbon, Portugal

Dates: from November 18, 2012 to November 23, 2012