visual resource

Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

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).

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

Please complete the form to access the visual resource.

*=Required

Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Download our Free ISO Comparison Matrix

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.

Interested in Learning More?

Contact Us