What does QSR stand for in regulatory affairs?

QSR stands for Quality System Regulations. This term is a crucial aspect of regulatory affairs, particularly in the context of ensuring that medical devices are manufactured and controlled in a manner that guarantees their safety and efficacy. The Quality System Regulations, as established by the FDA, outline the requirements for a quality management system that medical device manufacturers must adhere to.

These regulations serve as a framework that encompasses various aspects of product development and manufacturing, including design controls, production, installation, and servicing. By following QSR, companies can ensure quality throughout the product lifecycle, which ultimately protects public health.

The other options do not accurately reflect the established terminology within regulatory affairs related to quality systems for medical devices. For example, while a "Quality System Report" or "Quality Surveillance Review" may sound relevant, they do not represent official regulatory terms recognized by the FDA. Similarly, "Quality Security Regulations" does not correspond to any recognized standards or guidelines in this context. Thus, understanding that QSR specifically refers to Quality System Regulations is essential for anyone involved in regulatory affairs for medical devices.