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BY-NC-ND 4.0 license Open Access Published by De Gruyter September 22, 2018

Integrating a Usability Engineering Process into a Consisting Risk Management

  • Michael Scholtes EMAIL logo , Stephanie Buedenbender , Annemarie Behrend , Keywan Sohrabi and Volker Gross


The complexity of medical devices and its user interactions increases. A growing number of incident reports are assumed to be associated primarily with user errors. This development is tackled through current modifications in standards, such as ISO 13485:2016 and legislations, such as the Medical Device Regulation. Both intensify the focus on use errors significantly. The aim of this paper was the development of a process orientated approach integrating usability engineering into a consisting risk management based on a classic V-model. An appropriate procedure was worked out. For each development step, risk and usability activities were cumulated. Thus, the present paper might help medical device manufacturers to reflect their risk management and usability management processes to find synergies. Prospectively, a step-by-step guide for the integration of risk management and usability engineering based on this approach should be developed.

Published Online: 2018-09-22
Published in Print: 2018-09-01

© 2018 the author(s), published by Walter de Gruyter Berlin/Boston

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

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