The close correlation between the safety of medical devices and potential errors and dangers during their use is increasingly evident.
International Authorities, such as Notified Bodies in Europe, are increasingly attentive to the correct implementation by manufacturers of appropriate usability engineering methods in accordance with standards such as IEC 62366 and IEC 60601-1-6.
Maytal consultants can support companies, from the early stages of design, to provide the basis for designers and to support them in deciding how to carry out and implement usability engineering, as well as to propose practical solutions that allow the R & D sector to adequately manage the risks related to the usability of the product and, finally, to produce the necessary documentary evidence to support the usability validation process, prescribed by the IEC 62366 and IEC 60601-1-6 standards.