AAMI TIR38:2019

Medical device safety assurance case report guidance

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

Publisher: AAMI

File Format: PDF

$137.00$275.00

Description

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

Published:01/25/2019

Pages:51

File Size:1 file , 1.4 MB

Language:English

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

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.