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AAMI TIR38:2019

AAMI TIR38:2019 Medical device safety assurance case report guidance

standard by Association for the Advancement of Medical Instrumentation, 01/25/2019

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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.

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Published: 01/25/2019 Number of Pages: 51 File Size: 1 file , 1.4 MB

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