Integrating a Usability Engineering Process into a Consisting Risk Management

Abstract

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