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AAMI TIR38:2014

M00011020

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AAMI TIR38:2014 Medical device safety assurance case report guidance

standard by Association for the Advancement of Medical Instrumentation, 12/23/2014

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Provides guidance on how to complete an Assurance Case Report in order to comply with the new additional FDA pre-market requirements for infusion pumps. Includes a detailed but strictly hypothetical example from the medical device domain.