Configuration Management Process Improvement for the Medical Device Industry

McCaffery, Fergal and Coleman, Gerry (2006) Configuration Management Process Improvement for the Medical Device Industry. In: 6th International SPICE Conf. on Process Assessment and Improvement (SPICE 2006), 4th-5th May 2006, Luxembourg.

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Abstract

This paper outlines how the goals, practices and capability levels for the configuration management (CM) process area within a software process improvement (SPI) framework have been developed. This framework addresses an opportunity to integrate the regulatory issues and SPI mechanisms so as to achieve improvements that are critical to the development of software for medical devices [1]. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [2] (US requirement), and the European Commission under its Medical Device Directives (MDD) [3] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components.

Item Type:	Conference or Workshop Item (Paper)
Additional Information:	ISBN: 2-87978-047-0
Uncontrolled Keywords:	Software Process Improvement; Medical devices; Software; ISERC
Subjects:	Computer Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Sonya Grimley
Date Deposited:	24 Feb 2012 16:03
Last Modified:	11 Nov 2014 16:10
URI:	https://eprints.dkit.ie/id/eprint/148

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