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PDF IconRisk Management Series – Article 10: Human Factors Evaluation Report

Forward:

MEDIcept is very active in both assessing device usability and integrating the outputs of usability studies into other elements of manufacturers’ Quality Management Systems (QMS), particularly design control and risk management. This article is intended to provide some background on the application of the human factors/usability engineering process, but the focus is on the linkages between that process and the other elements of your QMS.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know:   508-231-8842.