Quality System Regulation

The Quality System Regulation (QSR) is a set of rules established by the FDA that medical device manufacturers must follow to ensure their products are safe, effective, and reliable. It covers all aspects of development, production, and distribution, including design controls, supervision of manufacturing processes, and thorough record-keeping. Essentially, QSR provides a structured framework that helps companies maintain high-quality standards and consistently produce safe medical devices, protecting patients and healthcare providers.