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AAMI TIR38:2014
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AAMI TIR38:2014 Medical device safety assurance case report guidance
standard by Association for the Advancement of Medical Instrumentation, 12/23/2014
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.Product Details
Edition: 1st Published: 12/23/2014 Number of Pages: 55File Size: 1 file , 1.7 MB
New product
AAMI TIR38:2014 Medical device safety assurance case report guidance
standard by Association for the Advancement of Medical Instrumentation, 12/23/2014