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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:
Choose Document Language:
$82.5
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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

History

AAMI TIR38:2019
AAMI TIR38:2019
Published Date: 01/25/2019
Medical device safety assurance case report guidance
$82.5

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