FDA QSR Insights

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.

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What other technologies are related to FDA QSR?

FDA QSR Complementary Technologies

ISO 13485

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. It is strongly related and complementary to FDA QSR.

mentioned alongside FDA QSR in 3% (352) of relevant job posts

EU MDR

The EU Medical Device Regulation (MDR) sets requirements for medical devices sold in the EU. While not directly the same, it covers similar ground as FDA QSR and is thus complementary.

mentioned alongside FDA QSR in 7% (64) of relevant job posts

MDSAP

The Medical Device Single Audit Program (MDSAP) allows a single audit of a medical device manufacturer's QMS to satisfy the requirements of multiple regulatory jurisdictions. It is thus complementary.

mentioned alongside FDA QSR in 4% (54) of relevant job posts