A roadmap to ISO 14971 implementation

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 on-line 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. The implementation of a risk management process for the medical device domain can be a costly and time consuming process, however this can be alleviated through the use of a software process improvement roadmap for risk management.