The Need for a Software Process Improvement Model for the Medical Device Industry

McCaffery, Fergal and Coleman, Gerry (2007) The Need for a Software Process Improvement Model for the Medical Device Industry. Int. Review on Computers and Software Journal. pp. 10-15.

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Software is becoming an increasingly important aspect of medical devices and medical device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of medical device software. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the medical device industry. The paper details how medical device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration ( CMMI®). Copyright © 2006 Praise Worthy Prize - All rights reserved.

Item Type: Article
Uncontrolled Keywords: Medical device; Software Process Improvement Model; CMMI®
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Sonya Grimley
Date Deposited: 09 Mar 2012 09:22
Last Modified: 11 Nov 2014 16:10

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