Usability Evaluation Plan
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Use this Usability Evaluation Plan template to systematically organize and document your planned usability testing activities, including formative and summative evaluations, for medical devices prior to market release as required by IEC 62366-1:2015 and risk management processes. Complete this plan during the product development phase to ensure all user interface hazards and critical tasks are identified, evaluated, and mitigated, supporting regulatory human factors engineering requirements.