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AAMI TIR102:2019

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems

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.

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Product Code:
TIR102-PDF
Date:
August 30, 2019
ISBN Number:
978-1-57020-724-2
Media:
PDF
Edition:
1
Pages:
146
Available for Immediate Download
AAMI Member:
$155.00
List Price:
$274.00
Your Price:
$274.00
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