Description: Due to increasing scrutiny of the MDR and IVDR on the usability of a device the role of the usability engineering file is more prominent. The strong relationship between Risk Management and Usability engineering is clearly visible when using guidance’s dealing with these topics (ISO 14971, TR24971, IEC 62366-1, IEC 62366-2) During this session we will take you through the world of usability and the differences between MDR regulated devices and IVDR regulated reagents. Struggles and best practices on how to maintain both the Risk Management File and Usability Engineering File will be discussed. With speakers from different disciplines (notified body, consultancy, and usability testing) different aspects will be highlighted.
Learning Objectives:
Usability requirements for IVDR from a notified body perspective
Ways to include the Usability data into the Risk Management File
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