Usability Validation
Usability Engineering in Medical Devices
There is an increasing recognition of the close relationship between medical device safety and potential errors or hazards during use.
International authorities, including Notified Bodies in Europe, are placing greater emphasis on the proper implementation of usability engineering by manufacturers, in accordance with standards such as IEC 62366 and IEC 60601-1-6.
Maytal consultants can support companies from the early stages of product design, providing designers with a solid foundation and guidance on implementation strategies for usability engineering. We help propose practical solutionsthat enable R&D teams to effectively manage usability-related risks and produce the necessary documented evidenceto support the usability validation process required by IEC 62366 and IEC 60601-1-6.
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