AAMI TIR38:2014 Historical

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Medical device safety assurance case report guidance

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

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Full Description

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. See more

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  1. AAMI TIR38:2019


    Medical device safety assurance case report guidance

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    Medical device safety assurance case report guidance

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Product Details

Edition:

1st

Published:

12/23/2014

Number of Pages:

55

File Size:

1 file

Note:

This product is restricted and cannot be purchased in the following countries Belarus, Russia, Ukraine