Integrating a Usability Engineering Process into a Consisting Risk Management

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 De...

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Bibliographic Details
Main Authors: Scholtes Michael, Buedenbender Stephanie, Behrend Annemarie, Sohrabi Keywan, Gross Volker
Format: Article
Language:English
Published: De Gruyter 2018-09-01
Series:Current Directions in Biomedical Engineering
Subjects:
Online Access:https://doi.org/10.1515/cdbme-2018-0155