TY - GEN
T1 - A risk management capability model for use in medical device companies
AU - Burton, John
AU - Caffery, Fergal Mc
AU - Richardson, Ita
PY - 2006
Y1 - 2006
N2 - 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.
AB - 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.
KW - Capability maturity model integration (cmmi)
KW - Hazard analysis
KW - Level of concern
KW - Medical device software
KW - Risk management
KW - Software process improvement
UR - http://www.scopus.com/inward/record.url?scp=84885576949&partnerID=8YFLogxK
U2 - 10.1145/1137702.1137705
DO - 10.1145/1137702.1137705
M3 - Conference contribution
AN - SCOPUS:84885576949
SN - 1595933999
SN - 9781595933997
T3 - Proceedings - International Conference on Software Engineering
SP - 3
EP - 8
BT - Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006
T2 - 2006 4th International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006
Y2 - 21 May 2006 through 21 May 2006
ER -
