BS EN 62366 Usability Engineering for Medical Devices

The key harmonised standard for medical device usability is BS EN 62366, Medical devices – Application of usability engineering to medical devices. This standard applies to all types of medical devices, both electrical and nonelectrical and should be used conjunction with ISO/IEC 14971 Application of risk management to medical devices.

Delivered in-house, this 1-day practical BS EN 62366 Usability Engineering course provides delegates with an understanding of usability engineering and how it should be applied to medical devices by examining all steps of the Usability Engineering Process.

The usability engineering process is specifically developed to reduce everyday errors, lessen risks and ensure general equipment safety. Human Factors and Usability Engineering in medical device design is also required by the FDA’s Quality System Regulation (QSR).

Directive 2007/47/EC, which came into effect in March 2010 and revised the Medical Device Directive, introduced much clearer and more specific usability requirements. Recital 18 of the directive stated “the need to consider ergonomic design and the training and knowledge of the user” in the essential requirements. Essential Requirement 1 of Annex I of the MDD was also revised, together with other requirements, to include these two additions.

This usability engineering workshop will develop the skills necessary to apply the usability engineering methodology in BS EN 62366 from analysing and specifying the design, identifying potential risks and verifying and validating the user interface.  Delegates will be able to extend the scope of their current risk management activities for medical devices to ensure the user interface is safe and effective.

This course compliments Bywater’s other auditor courses applicable to the Medical Device industry.