A Software Process Improvement Lifecycle Framework for the Medical Device Industry

McCaffery, Fergal and McFall, D and Donnelly, Peter and Wilkie, F.G and Sterrit, Roy (2005) A Software Process Improvement Lifecycle Framework for the Medical Device Industry. In: 12th Annual IEEE International Conference on the Engineering of Computer Based Systems (ECBS 2005), 3rd-8th April 2005, Marriott Hotel, Greenbelt, Maryland, USA.

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This paper describes a software process improvement framework to ensure regulatory compliance for the software developed in medical devices. 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) [1] (US requirement), and the European Commission under its Medical Device Directives (MDD) [2] (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:0-7695-2308-0
Uncontrolled Keywords: Medical devices; Regulatory compliance; FDA; MDD; Software components
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Sonya Grimley
Date Deposited: 24 Feb 2012 15:59
Last Modified: 11 Nov 2014 16:10

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