U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
Also Known As:
SKU113413239
Published by
Association for the Advancement of Medical Instrumentation
AAMI
Publication Date2019-08-30
Pages CountPages146
Full Description
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.
Details
| ICS Codes | 03.100 - Company organization and management. Management systems 11.040 - Medical equipment |
| Language(s) | English |
| ISBN | 9781570207242 |
| File Size | 2.6 MB |
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