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Technical-File-Template-Medical-Device

UEF- UOUP Template

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UEF-UOUP-Template

This template is designed to guide manufacturers in establishing, documenting, and maintaining robust usability engineering processes for medical devices. It serves as a cornerstone in ensuring the safety of device use, addressing risks associated with use errors that could potentially compromise safety or clinical functionality.

Within this template, we establish and document the critical link between usability, essential requirements, and risk management, ensuring device safety. By integrating usability considerations into essential requirements and risk management processes, manufacturers can mitigate potential hazards and enhance overall device safety. Moreover, this document provides a justification for conducting usability evaluations, particularly for devices subject to the Evaluation of a User Interface of Unknown Provenance (UOUP) protocol. By clearly documenting the rationale behind usability evaluations, manufacturers can demonstrate compliance with regulatory requirements and ensure the safety and efficacy of their devices.

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

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