AAMI TIR38 PDF

AAMI TIR38 PDF

$150.00

Medical device safety assurance case report guidance

Published by Publication Date Number of Pages
AAMI 01/25/2019 51
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Description

AAMI TIR38 – Medical device safety assurance case report 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.

Product Details

Published:
01/25/2019
Number of Pages:
51
File Size:
1 file , 1.4 MB
Note:
This product is unavailable in Russia, Ukraine, Belarus

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