This combines the FDA's Quality System Regulation (QSR) regulations and ISO 13485. It refers to the set of standards and regulations that govern the quality management systems of medical device manufacturers. 

These regulations outline the processes, procedures, and documentation required to ensure that medical devices are consistently designed, produced, and controlled to meet specified quality standards. 

The aim is to ensure the safety and effectiveness of medical devices throughout their lifecycle, from design and manufacturing to distribution and post-market surveillance. In the U.S., the FDA enforces these requirements under 21 CFR Part 820, while internationally, ISO 13485 is widely recognized as the standard for medical device quality management systems.