MedeSPI: A Software Process Improvement Model for the Medical device industry based upon Automotive SPICE

McCaffery, Fergal and Richardson, Ita (2007) MedeSPI: A Software Process Improvement Model for the Medical device industry based upon Automotive SPICE. In: International Spice Days 2007 Conference, 18th-20th June 2007, Frankfurt, Germany.

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Abstract

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 extending relevant practices from Automotive SPICE.

Item Type:	Conference or Workshop Item (Paper)
Additional Information:	Session 3-A4
Uncontrolled Keywords:	Medical device industry; FDA; Regulatory requirements; Automotive SPICE
Subjects:	Computer Science
Research Centres:	Regulated Software Research Centre
Depositing User:	Sonya Grimley
Date Deposited:	24 Feb 2012 16:00
Last Modified:	11 Nov 2014 16:10
URI:	https://eprints.dkit.ie/id/eprint/131

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