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AAMI TIR38:2019

Medical device safety assurance case report guidance

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

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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.
 

Product Details

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

Document History

  1. AAMI TIR38:2019

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    Medical device safety assurance case report guidance

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  2. AAMI TIR38:2014


    Medical device safety assurance case report guidance

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