Description
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.
Product Details
- 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