A Risk Management Capability Model for use in Medical Device Companies

Burton, John and McCaffery, Fergal and Richardson, Ita (2006) A Risk Management Capability Model for use in Medical Device Companies. In: 4th Workshop on Software Quality, ICSE 2006, 21st May 2006, Shanghai.

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Medical device software is a risky business. Failure of the software can have potentially catastrophic effects, leading to injury of patients or even death. It is therefore no surprise that regulators throughout the world are penalising medical device manufacturers that do not demonstrate that sufficient attention is devoted to the areas of hazard analysis and risk management (RM) throughout the software lifecycle. If a medical device company fails to comply with the regulations of a given country, in effect they surrender their legal right to market their device in that country. With so much at stake, it is in everybody’s best interest that the medical device manufacturer gets it right. However, with so many different standards, regulatory guidance papers and industry guides on RM, the task of collating this information into a usable model is itself daunting. This paper seeks to extract the important concepts from a number of industry accepted standards and guides, and present them as a generic usable model for the medical device software industry.

Item Type: Conference or Workshop Item (Paper)
Uncontrolled Keywords: Hazard analysis; Risk management; Level of concern; Medical device software; Software process improvement; Capability Maturity Model Integration (CMMI®)
Subjects: Computer Science
Research Centres: Regulated Software Research Centre
Depositing User: Sonya Grimley
Date Deposited: 24 Feb 2012 16:01
Last Modified: 11 Nov 2014 16:10

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