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AAMI TIR38:2019

Medical device safety assurance case guidance

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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TIR382019PDF
January 25, 2019
978-1-57020-712-9
PDF
51
$137.00
$243.00
$243.00
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