What does the Quality System Regulation (QSR) for medical devices (21CFR 820) pertain to?

The Quality System Regulation (QSR), as outlined in 21 CFR 820, applies to finished medical devices and their accessories. This regulation establishes a framework that ensures that medical devices are designed and manufactured according to regulatory requirements, resulting in products that are safe and effective for consumers.

The inclusion of accessories to finished devices in the QSR is significant because these accessories can impact the performance and safety of the medical device as a whole. Accessories can contribute to the intended use of the device, meaning the quality assurance processes established by the QSR also apply to these supplementary products.

This understanding reflects the importance of comprehensive quality management in the device manufacturing process. By encompassing finished devices and their accessories, the QSR ensures that all aspects of a medical product that might affect its safety and efficacy are adequately controlled and monitored, promoting overall quality in medical device manufacturing.