Quality System Regulation (QSR)

The Quality System Regulation (QSR) is a set of rules established by the U.S. Food and Drug Administration (FDA) to ensure that medical devices are designed, manufactured, and distributed safely and effectively. It requires companies to have standardized procedures for quality control, proper documentation, regular inspections, and corrective actions. This helps ensure that medical devices meet consistent safety standards, reducing risks to patients and users. Essentially, QSR creates a framework for companies to maintain high-quality products through systematic processes, accountability, and continuous improvement.