With the implementation of the new European Medical Device Regulation (MDR), usability has become a crucial requirement for the market approval of medical devices.
This webinar aims to provide an in-depth understanding of the importance of usability throughout the design and post-market phases, offering an overview of the regulatory obligations that manufacturers must adhere to under the MDR, as well as the IEC 62366-1 standard, which serves as a key reference for usability design.
Additionally, the usability engineering process will be explored within the context of risk management, with a particular focus on the preparation of the usability file.
Registration is only granted to medical device company manufacturers and partners.
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