Human Factors and Usability Engineering Procedure

The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists medical device design teams in following appropriate human factors and usability engineering processes to ensure new medical devices will be safe and effective for the intended users, uses and use environments.

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Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure

The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure assists medical device design teams in following appropriate human factors and usability engineering processes to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses and use environments.

Human Factors and Usability Engineering Procedure - Overview

The Human Factors Engineering (HFE) and Usability Engineering (UE) Procedure applies to human factors or usability engineering processes utilized during the development of new medical devices, with a primary focus on the user interface, where the user interface includes all points of interaction between the product and the user(s) including elements such as displays, controls, packaging, product labels, instructions for use, etc.