The Impact of Fuzzy Requirements on Medical Device Software Development

Martin McHugh; Abder-Rahman Ali, Université d'Auvergne Abder-Rahman Ali, Université d'Auvergne; Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland

doi:10.21427/r0ws-x837

The Impact of Fuzzy Requirements on Medical Device Software Development

Martin McHugh, Abder-Rahman Ali, Université d'Auvergne Abder-Rahman Ali, Université d'Auvergne, Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland

Technological University Dublin

Research output: Contribution to conference › Paper › peer-review

Abstract

Any software development project can experience difficulties with unclear or vague requirements. Unfortunately, this problem can be experience two fold in regulated environments such as the medical device software development industry. In the medical device software development industry, development organisations must contend with vague or “fuzzy” both the customer and regulatory bodies. As new requirements are introduced they can have a knock on effect on other requirements. These requirements should be analysed to determine if they are conflicting, cooperative, mutually exclusive and irrelevant. Only when the requirement is classified can a clear method be established as how to integrate that requirement with previous ones. Medical device software organisations could benefit from understanding the impact of fuzzy requirements as it could result in reduced rework at a later stage in the project.

Original language	English
DOIs	https://doi.org/10.21427/r0ws-x837
Publication status	Published - 2014
Event	European Systems and Software Process Improvement and Innovation Conference EuroSPI - Luxembourg, Luxembourg Duration: 25 Jun 2014 → 27 Jun 2014

Conference

Conference	European Systems and Software Process Improvement and Innovation Conference EuroSPI
Country/Territory	Luxembourg
City	Luxembourg
Period	25/06/14 → 27/06/14

Keywords

unclear requirements
vague requirements
medical device software development
regulated environments
customer requirements
regulatory bodies
conflicting requirements
cooperative requirements
mutually exclusive requirements
irrelevant requirements
rework

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10.21427/r0ws-x837Licence: CC BY-NC-SA

Cite this

McHugh, M., Abder-Rahman Ali, Université d'Auvergne, A.-R. A. U. DA., & Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland, F. M. D. I. O. T. D. I. (2014). The Impact of Fuzzy Requirements on Medical Device Software Development. Paper presented at European Systems and Software Process Improvement and Innovation Conference EuroSPI, Luxembourg, Luxembourg. https://doi.org/10.21427/r0ws-x837

McHugh, Martin ; Abder-Rahman Ali, Université d'Auvergne, Abder-Rahman Ali, Université d'Auvergne ; Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland, Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland. / The Impact of Fuzzy Requirements on Medical Device Software Development. Paper presented at European Systems and Software Process Improvement and Innovation Conference EuroSPI, Luxembourg, Luxembourg.

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McHugh, M, Abder-Rahman Ali, Université d'Auvergne, A-RAUDA & Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland, FMDIOTDI 2014, 'The Impact of Fuzzy Requirements on Medical Device Software Development', Paper presented at European Systems and Software Process Improvement and Innovation Conference EuroSPI, Luxembourg, Luxembourg, 25/06/14 - 27/06/14. https://doi.org/10.21427/r0ws-x837

The Impact of Fuzzy Requirements on Medical Device Software Development. / McHugh, Martin; Abder-Rahman Ali, Université d'Auvergne, Abder-Rahman Ali, Université d'Auvergne; Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland, Fergal McCaffery, Dundalk Institute of Technology, Dundalk, Ireland.
2014. Paper presented at European Systems and Software Process Improvement and Innovation Conference EuroSPI, Luxembourg, Luxembourg.

Research output: Contribution to conference › Paper › peer-review

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AB - Any software development project can experience difficulties with unclear or vague requirements. Unfortunately, this problem can be experience two fold in regulated environments such as the medical device software development industry. In the medical device software development industry, development organisations must contend with vague or “fuzzy” both the customer and regulatory bodies. As new requirements are introduced they can have a knock on effect on other requirements. These requirements should be analysed to determine if they are conflicting, cooperative, mutually exclusive and irrelevant. Only when the requirement is classified can a clear method be established as how to integrate that requirement with previous ones. Medical device software organisations could benefit from understanding the impact of fuzzy requirements as it could result in reduced rework at a later stage in the project.

KW - unclear requirements

KW - vague requirements

KW - medical device software development

KW - regulated environments

KW - customer requirements

KW - regulatory bodies

KW - conflicting requirements

KW - cooperative requirements

KW - mutually exclusive requirements

KW - irrelevant requirements

KW - rework

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M3 - Paper

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ER -

The Impact of Fuzzy Requirements on Medical Device Software Development

Abstract

Conference

Keywords

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