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.
AAMI TIR38:2014
Original price was: $260.00.$130.00Current price is: $130.00.
Medical device safety assurance case report guidance
Association for the Advancement of Medical Instrumentation , 12/23/2014
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