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AAMI TIR102 PDF
Original price was: $290.00.$174.00Current price is: $174.00.
U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
| Published by | Publication Date | Number of Pages |
| AAMI | 08/30/2019 | 146 |
AAMI TIR102 – 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.
| Published | 08/30/2019 |
|---|---|
| ISBN(s) | 9781570207242 |
| Number of Pages | 146 |
| File Size | 1 file , 1.1 MB |
| Note | This product is unavailable in Russia, Ukraine, Belarus |
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