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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

Association for the Advancement of Medical Instrumentation , 08/30/2019

Publisher: AAMI

File Format: PDF

$159.00$319.00


Standard By:Association for the Advancement of Medical Instrumentation , 08/30/2019
Published:08/30/2019
Pages:146
ISBN(s):9781570207242
File Size:1 file , 1.1 MB
Language:English
Note:This product is unavailable in Belarus, Russia, Ukraine
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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