Out-of-the-Box Medical Device Safety

Executive Summary: Out-of-the-box experience is an important consideration in medical device design that not only impacts the user’s impression of the product, but can also have critical safety implications related to IEC 62366-1. This article discusses the basic safety questions to contemplate in a use-related risk analysis pertaining to the out-of-the-box experience, and focuses on how the most critical safety risks can be reduced through human factors engineering by conducting usability studies related to the out-of-the-box experience.

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