SOP Usability Engineering
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Use this SOP Usability Engineering template to systematically manage all usability engineering activities for your medical device, from user research and requirements gathering to formative and summative usability testing and post-market monitoring. Completing this SOP is essential for demonstrating compliance with IEC 62366-1 and FDA usability guidance, and it should be filled out throughout the design, development, verification, and post-market phases to ensure user needs, safety, and regulatory requirements are consistently met.