AAMI TIR38:2019

Medical device safety assurance case report guidance

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

$138.00 $275.00
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 Information

Published: 01/25/2019
Pages: 51
File Size: 1 file , 1.4 MB
Language: English
Note: This product is unavailable in Belarus, Russia, Ukraine
AAMI TIR38:2019
AAMI TIR38:2019

$138.00

AAMI TIR38:2014
AAMI TIR38:2014

$130.00

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