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.

Product Details

Published: 08/30/2019 ISBN(s): 9781570207242 Number of Pages: 146 File Size: 1 file , 1.1 MB