AAMI TIR38:2019 PDF

AAMI TIR38:2019 PDF

Name:
AAMI TIR38:2019 PDF

Published Date:
01/25/2019

Status:
Active

Description:

Medical device safety assurance case report guidance

Publisher:
Association for the Advancement of Medical Instrumentation

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

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.

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

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