IEC 62366 (now superseded by IEC 62366-1:2015 and IEC 62366-2:2020) addresses the application of usability engineering to medical devices. It specifies a process for medical device manufacturers to analyze, specify, design, verify, and validate the usability of their products. The goal is to reduce use errors and associated risks, thereby enhancing patient safety. It is commonly used by medical device manufacturers to demonstrate compliance with regulatory requirements related to usability and human factors engineering.
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