Usability Evaluation Protocol
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Use this Usability Evaluation Protocol template to systematically plan and document your medical device user interface summative usability testing, focusing on critical and hazard-related use scenarios as required by IEC 62366-1:2015. This protocol ensures that all necessary user tests are outlined, tracked, and evaluated, supporting your risk management and design verification processes. Complete this document before conducting usability testing to demonstrate compliance and capture essential data for your Usability Evaluation Report.