Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements
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Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and / or maintaining a robust and comprehensive global Quality Management System (QMS).
Our Comparison Matrix provides a summary overview of the regulation and the standard in a simple and easy-to-use table format.
What is your QMS and how does it stand up to the International Standard and applicable regulatory requirements? Who determines the processes, sequences, and interactions of these processes? View our chart and compare how close—or far—you are to meeting QMS regulations for your device.