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IEC 60601-1 EUV Requirement Comparison Guide

Post-pandemic approval for Emergency Use Authorization (EUA) products

Multiple ventilators and respirators in stock in a clinic warehouse

The FDA’S expedited approval process has been put in place to assist healthcare manufacturers get needed products to market during the current pandemic. However, these product exceptions will not be honored post-pandemic. This technical report will help you understand the gaps that will need to be addressed before final regulatory clearances.

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