Usability is an integral part of medical device development. Thus, it is important to understand how users may interact with a device, in order to ensure proper function and avoid safety issues.
The IEC 62366-1 standard describes the various activities that should be implemented in a usability engineering process to fulfill the requirements of the MDR.
This webinar is an introduction to the IEC62366-1 standard. Its history, regulatory context and the essence of the standard will be covered, as well as basic terminology and definitions. An overview of the usability engineering process according to the standard is given.
Everyone involved in medical device development, including quality and regulatory professionals, will benefit from this presentation.
The presentation will be in English. We use Zoom for video conferencing.
Cilla Lundevall, Senior Quality and Regulatory Consultant.
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