Question

The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of which of the following:

A) Finished devices, but not accessories
B) Finished devices and components of finished devices
C) Finished devices and accessories to finished devices
D) Finished devices, components, and accessories to finished devices

Answer 1

The Quality System Regulation (QSR) for medical devices pertains to the manufacturing of finished devices, components, and accessories to finished devices.

Step-by-step explanation:

The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to the manufacturing of finished devices, components, and accessories to finished devices. This means that the QSR covers not only the production of complete medical devices, but also the individual parts and accessories that make up those devices.