FDA Finalizes U.S. Quality Regulations with ISO 13485: What Medical Device Manufacturers Need to Know

United States – 24 October 2025 – The U.S. Food and Drug Administration (FDA) has announced a major change to the way medical device manufacturers manage quality systems. In January 2024, the agency issued a final rule revising 21 CFR Part 820, known as the Quality System Regulation (QSR). This update brings the U.S. framework […]