AAMI TIR102:2019

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This document provides a mapping of the US FDA 21 CFR requirements to the “regulatory requirements” references in ISO 13485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.

Product Details

Published:

08/30/2019

ISBN(s):

9781570207242

Number of Pages:

146

File Size:

1 file , 1.1 MB