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Updated EU standard for improving device usability addresses legacy products

This article was originally published in Clinica

Executive Summary

The European standard on application of usability engineering to medical devices, EN 62366:2008, has been amended with new requirements pertaining to legacy devices where the user interface was created before the standard came into use. This update is particularly relevant to large medtech companies who are more likely to have many legacy devices in their sizeable portfolios.

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