The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation ...

FDA has just published a 101-page rule titled “Medical Devices; Quality System Regulation Amendments,” finalizing the February 2022 proposed rule of the same name. It aims to harmonize FDA ...

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

In the highly regulated world of life sciences, quality isn’t a box to check—it’s a business imperative. For global en ...

The FDA's Quality Management System Regulation aligns U.S. standards with ISO 13485 for medical devices, promoting global consistency in quality management.