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Current Directions in Biomedical Engineering

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Buzug, Thorsten M. / Haueisen, Jens / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Kraft, Marc / Lenarz, Thomas / Leonhardt, Steffen / Malberg, Hagen / Penzel, Thomas / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Urban, Gerald A.

CiteScore 2018: 0.47

Source Normalized Impact per Paper (SNIP) 2018: 0.377

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Integrating a Usability Engineering Process into a Consisting Risk Management

Michael Scholtes / Stephanie Buedenbender / Annemarie Behrend / Keywan Sohrabi / Volker Gross
Published Online: 2018-09-22 | DOI: https://doi.org/10.1515/cdbme-2018-0155


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.

Keywords: Risk Management; Usability; Regulatory Affairs

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Published Online: 2018-09-22

Published in Print: 2018-09-01

Citation Information: Current Directions in Biomedical Engineering, Volume 4, Issue 1, Pages 645–647, ISSN (Online) 2364-5504, DOI: https://doi.org/10.1515/cdbme-2018-0155.

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