A roadmap to ISO 14971 implementation (pages 319–336)
Derek Flood, Fergal McCaffery, Valentine Casey, Ruth McKeever and Peter Rust
Article first published online: 14 APR 2015 | DOI: 10.1002/smr.1711
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. Experienced risk management personnel in the medical device domain were asked to complete an on-line questionnaire examining their opinion on the structure and content of the roadmap. This paper presents the findings.