A risk management capability model for use in medical device companies

John Burton; Fergal Mc Caffery; Ita Richardson

doi:10.1145/1137702.1137705

A risk management capability model for use in medical device companies

John Burton
, Fergal Mc Caffery
, Ita Richardson

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

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.

Original language	English
Title of host publication	Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006
Pages	3-8
Number of pages	6
DOIs	https://doi.org/10.1145/1137702.1137705
Publication status	Published - 2006
Event	2006 4th International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006 - Shanghai, China Duration: 21 May 2006 → 21 May 2006

Publication series

Name	Proceedings - International Conference on Software Engineering
ISSN (Print)	0270-5257

Conference

Conference	2006 4th International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006
Country/Territory	China
City	Shanghai
Period	21/05/06 → 21/05/06

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 9 Industry, Innovation, and Infrastructure

Keywords

Capability maturity model integration (cmmi)
Hazard analysis
Level of concern
Medical device software
Risk management
Software process improvement

Access to Document

10.1145/1137702.1137705

Cite this

Burton, J., Caffery, F. M., & Richardson, I. (2006). A risk management capability model for use in medical device companies. In Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006 (pp. 3-8). (Proceedings - International Conference on Software Engineering). https://doi.org/10.1145/1137702.1137705

Burton, John ; Caffery, Fergal Mc ; Richardson, Ita. / A risk management capability model for use in medical device companies. Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006. 2006. pp. 3-8 (Proceedings - International Conference on Software Engineering).

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title = "A risk management capability model for use in medical device companies",

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.",

keywords = "Capability maturity model integration (cmmi), Hazard analysis, Level of concern, Medical device software, Risk management, Software process improvement",

author = "John Burton and Caffery, \{Fergal Mc\} and Ita Richardson",

year = "2006",

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language = "English",

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series = "Proceedings - International Conference on Software Engineering",

pages = "3--8",

booktitle = "Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006",

note = "2006 4th International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006 ; Conference date: 21-05-2006 Through 21-05-2006",

}

Burton, J, Caffery, FM & Richardson, I 2006, A risk management capability model for use in medical device companies. in Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006. Proceedings - International Conference on Software Engineering, pp. 3-8, 2006 4th International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006, Shanghai, China, 21/05/06. https://doi.org/10.1145/1137702.1137705

A risk management capability model for use in medical device companies. / Burton, John; Caffery, Fergal Mc; Richardson, Ita.
Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006. 2006. p. 3-8 (Proceedings - International Conference on Software Engineering).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

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AU - Caffery, Fergal Mc

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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.

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KW - Level of concern

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KW - Risk management

KW - Software process improvement

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BT - Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006

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ER -

Burton J, Caffery FM, Richardson I. A risk management capability model for use in medical device companies. In Proceedings of the 2006 International Workshop on Software Quality, WoSQ 2006, Co-Located with the 28th International Conference on Software Engineering, ICSE 2006. 2006. p. 3-8. (Proceedings - International Conference on Software Engineering). doi: 10.1145/1137702.1137705

A risk management capability model for use in medical device companies

Abstract

Publication series

Conference

UN SDGs

Keywords

Access to Document

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