A risk management capability model for use in medical device companies

Authors:
John Burton;Fergal McCaffery;Ita Richardson
Affiliations:
Vitalograph Ltd., Ennis, Ireland;University of Limerick, Ireland;University of Limerick, Ireland
Venue:
Proceedings of the 2006 international workshop on Software quality
Year:
2006

Citing 0
Cited 4

Enabling the adoption of aspects - testing aspects: a risk model, fault model and patterns

Proceedings of the 8th ACM international conference on Aspect-oriented software development
Risk management capability model for the development of medical device software

Software Quality Control
Improving software risk management practices in a medical device company

ICSP'08 Proceedings of the Software process, 2008 international conference on Making globally distributed software development a success story
Medical device standards' requirements for traceability during the software development lifecycle and implementation of a traceability assessment model

Computer Standards & Interfaces

Quantified Score

Hi-index	0.00

Visualization

Abstract

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.