AAMI TIR38:2014

Medical device safety assurance case report guidance

Association for the Advancement of Medical Instrumentation , 12/23/2014

Publisher: AAMI

File Format: PDF

$130.00$260.00

Description

Standard By:Association for the Advancement of Medical Instrumentation , 12/23/2014

Published:12/23/2014

Pages:55

File Size:1 file , 1.7 MB

Language:English

Note:This product is unavailable in Belarus, Russia, Ukraine

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.

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