Use errors caused by inadequate Medical Device Usability have become an increasing cause for concern for Regulators, Medical Device Manufacturers and Healthcare providers alike. Many of the Medical Devices developed without applying a Usability (Human Factors) Engineering process are non-intuitive, difficult to learn and difficult to use. It is the responsibility of the Medical Device manufacturer to reduce all risk as far as possible including usability-related risks. A functioning Usability Engineering process is essential for the Medical Manufacturer in attempting to minimise risk associated with the usability of their devices. This course outlines the requirements for a Usability Process as defined by EN IEC 62366 and the guidance available from the MHRA and the US FDA. The course guides attendees thought the establishment of a Usability Process, how to achieve compliance with EN IEC 62366 and how to use the standard to minimise usability-related risks. The course involves interactive group exercises throughout. The training includes an end-of-course assessment which helps to embed the learning. Attendees who pass the assessment receive a certificate of achievement.
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