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A roadmap to ISO 14971 implementation
Author(s) -
Flood Derek,
McCaffery Fergal,
Casey Valentine,
McKeever Ruth,
Rust Peter
Publication year - 2015
Publication title -
journal of software: evolution and process
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.371
H-Index - 29
eISSN - 2047-7481
pISSN - 2047-7473
DOI - 10.1002/smr.1711
Subject(s) - technology roadmap , domain (mathematical analysis) , engineering management , process management , computer science , engineering , business , mathematical analysis , mathematics , marketing
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. Copyright © 2015 John Wiley & Sons, Ltd.