Description

AAMI TIR38 – Medical device safety assurance case report guidance

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

Note:

This product is unavailable in Russia, Ukraine, Belarus