UEP- UOUP Template

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This template is designed to guide manufacturers in integrating crucial human factors and usability considerations into the design and development process of medical devices. This meticulously crafted document outlines a systematic approach aimed at optimizing the usability of devices, ensuring they effectively meet the needs and capabilities of their intended users.

Within this template, manufacturers will find detailed methodologies, objectives, and responsibilities delineated for evaluating and enhancing device usability. By following this structured approach, manufacturers can ensure that their devices prioritize safety, task accuracy, completeness, efficiency, and user satisfaction. Moreover, this document serves as a valuable resource for justifying the usability evaluations conducted, particularly for devices subject to evaluation under the Evaluation of a User Interface of Unknown Provenance (UOUP) protocol.

It is designed by highly experienced professionals for all medical device companies. Click below to get a preview of this template.