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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
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Summary
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. No annex
Technical characteristics
| Publisher | Association for the Advancement of Medical Instrumentation (AAMI) |
| Publication Date | 01/01/2019 |
| Page Count | 146 |
| Themes | Quality Systems/Regulatory Affairs |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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