The webinar "Usability Techniques for Compliance: the Use of Annex C of the IEC 62366 Standard" aims to provide an overview of Annex C, focusing on its application for user interfaces or parts of user interfaces of devices already on the market.
A common scenario faced by manufacturers involves the transition from Directive 93/42/EEC to the new Medical Devices Regulation (EU) 2017/745, which includes legacy devices that have not been fully designed and evaluated from usability point of view according to the entire usability engineering process outlined in the IEC 62366-1 standard.
Annex C has been specifically developed to assist manufacturers in evaluating the usability of legacy devices, or parts of such devices, referred to as "devices of unknown provenance." The key points of Annex C will be analysed to allow for the creation of a usability engineering dossier for legacy devices compliant with the requirements of the IEC 62366-1.
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