Requirements capture for medical device design

Conference paper (2003)

Authors

James Ward University of Cambridge

S Shefelbine

P.J. Clarkson External organisation

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Best practice Medical devices Introduction of methods Requirements capture

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Published Date

2003

Language

English

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Abstract

There are many examples from the medical device design industry where poor requirements capture practice has led to post-market problems, including patient morbidity and mortality. There is a clear need to improve this process. The purpose of this paper is to present the results of several years of study by five researchers into the requirements capture process in this area of industry and to highlight the need by industry for further guidance. Various research methods were used to investigate the requirements capture problem and to develop and evaluate a workbook which provides guidance for designers. The workbook consists of a package of methods: a functional analysis approach, a matrix-based checklist and advice on regulatory requirements. It has been refined over the years and is now published [1] The matrix also forms part of a publication for the UK Department for Trade and Industry [2], and a web version is under development.