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.

Date of Publication: 30 August 2019

Pages: 146

ISBN: 978-1-57020-724-2