Understanding & Complying with the Updated 21 CFR 820 Quality Management System Regulation for Medical Device Manufacturers

This white paper provides a comprehensive analysis of the recent updates to the FDA’s 21 CFR 820 regulations for medical device manufacturing, aligning with ISO 13485. It covers the key differences between the regulatory frameworks, the implications for manufacturers, and how these changes impact compliance strategies. Readers will gain insight into implementation timelines, regulatory expectations, and actionable steps to ensure continued compliance in the evolving regulatory landscape.