This presentation provides an overview of the Quality Management System Regulation, including preamble and final rule, a review of some important definitions and their hierarchy of application, and a ...

In the changing field of technology, progress is driven by the pursuit of innovation which plays a vital role in enhancing patient care, prolonging lives, and improving overall healthcare outcomes.

On February 2, 2026, the FDA stopped using the Quality System Inspection Technique (QSIT) for device inspections and began ...

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 ...