What is FDA QSR?

The FDA Quality System Regulation (QSR) specifies requirements related to the methods and controls used in designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use. It ensures that medical devices are safe, effective, and meet applicable regulations. Manufacturers must establish and follow a quality system that addresses areas such as design controls, purchasing controls, production and process controls, corrective and preventive action (CAPA), and records management. The QSR is commonly used by medical device companies to demonstrate compliance with FDA requirements and to ensure the quality and reliability of their products.