However, there are differences between QSR/cGMP compliance and ISO certification. Relationship between FDA-QSR 21 CFR 820 and ISO 13485? They have several differences. ISO is a standard based on ISO 9001. ISO 13485 to FDA QSR. Gray S Anatomy Review 2nd Edition Pdf.

Whitepaper – ISO13485 & US FDA CFR 820 Comparison Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the international market. So how do the quality management system requirements compare?

This white paper highlights the strengths and weaknesses of the ISO standard and the FDA regulation, as well as their key differences. Purpose This white paper provides a comparison of the Quality Management System (QMS) requirements between the US FDA 21 CFR Part 820 regulation and the international ISO 13485 standard. Audience This White Paper is written to assist anyone involved in marketing medical devices around the world. You can download the whitepaper “Comparison of Medical Device Standards and Regulations – ISO13485 and US FDA CFR part 820”.