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Full Description

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.
 

Document History

  1. AAMI TIR38:2019

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    Medical device safety assurance case report guidance

    • Most Recent
  2. AAMI TIR38:2014


    Medical device safety assurance case report guidance

    • Historical Version