A roadmap to ISO 14971 implementation

Rust, Peter and McCaffery, Fergal and Casey, Valentine and McKeever, Ruth and Flood, Derek (2015) A roadmap to ISO 14971 implementation. Journal of Software: Evolution and Process, 27 (5). ISSN 2047-7481

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Abstract

Medical device standards outline the requirements for developing medical devices. These standards, however, do not outline how these requirements should be implemented causing difficulties for organisations entering the medical device domain. The goal of this study is to validate a roadmap for the implementation of the ISO 14971 standard. The validation examined the arrangement of the milestones within the roadmap and grouping of the goals into milestones. Five experienced risk management personnel in the medical device domain were asked to complete an online questionnaire examining their opinion on the structure and content of the roadmap. Overall participants found the roadmap, in general, to be well structured and well organised and made some recommendations for improving the roadmap through merging of specific goals and rearrangement of the milestones within the roadmap.

Item Type:	Article
Uncontrolled Keywords:	Medical device software; Medical device standards; Regulatory compliance; Risk management; ISO 14971; Software roadmap.
Subjects:	Computer Science > Computer Software
Research Centres:	Regulated Software Research Centre
Depositing User:	Sean McGreal
Date Deposited:	11 Nov 2016 13:54
Last Modified:	11 Nov 2016 13:54
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/547

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