US FDA recognised the need for user-centred design as far back as the 1990’s, and published their guidance “Do it by Design, an Introduction to Human Factors in Medical Devices” in 1996. The importance of the device-user interaction has evolved over the intervening period, and the demonstration of device usability is now integral to medical device submissions globally.

The introduction of the usability engineering ISO standard in 2007, also more recently updated in 2015, marked the widespread acceptance of the need to fully consider the device user in the design; with the aim of identifying and mitigating ‘use errors’.

ARC Regulatory has significant experience in working with development teams to ensure that the requirements of the device-user interface are fully understood; the primary operating functions and functions related to safety are identified, and studies are implemented at appropriate stages of device development, to understand how the user interacts and use error is mitigated as far as possible - all in the context of an over-arching risk management system in compliance with ISO 14971.


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