This technical information report 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. It includes a detailed but strictly hypothetical example from the medical device domain.
AAMI TIR38:2019
Original price was: $275.00.$137.00Current price is: $137.00.
Medical device safety assurance case report guidance
Association for the Advancement of Medical Instrumentation , 01/25/2019
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