Difference Between ISO 13485 and 21 CFR 820: Key Distinctions in Medical Device Quality Standards
The difference between ISO 13485 and 21 CFR 820 lies in their scope and approach to medical device quality management. ISO 13485 is an international standard focusing on risk-based quality management, emphasizing global compliance, risk management, and post-market surveillance. In contrast, 21 CFR 820 is a U.S.-specific FDA regulation focused on device safety and effectiveness…