The Usability Evaluation Plan outlines the activities and resources needed for conducting Usability Evaluation for the device. Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 4.2 Usability Engineering File (all) 4.3 Tailoring the Usability Engineering effort […]
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Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 5.4 Identification and Description of Hazard-Related Use Scenarios 1 5.5 Selection of Hazard-Related Use Scenarios for Summative Evaluation 1 Overview The purpose of the Hazard-Related Use Scenarios list
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Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 4.2 Usability Engineering File (all) 4.3 Tailoring of the Usability Engineering effort (all) 1. User Group and Testing Environment Detail the user group here, such as physicians with
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This table correlates the requirements from IEC 62366-1:2015 (organized by section) to their respective documents. Please note that the document titles in the “Fulfilled in Document” column are based on OpenRegulatory templates. You may have a different naming convention for
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The Usability Evaluation Report provides a summary of the results from all usability evaluation activities, including both formative and summative assessments. Mapping Standard Requirements to Document Sections IEC 62366-1:2015 Section Title Document Section 4.1.3 Information for Safety related to Usability
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