Question

The QSR for medical devices (21CFR 820) requires all of the following except:

A) Management to make a commitment to quality
B) A Quality Plan that defines how quality will be met
C) Management must review the Quality System at least quarterly
D) A Quality representative must be identified and documented

Answer 1

The Quality System Regulation for medical devices requires management commitment to quality, a Quality Plan, and a Quality representative, but does not specify a requirement for quarterly management reviews.

Step-by-step explanation:

The Quality System Regulation (QSR) for medical devices (21CFR 820) outlines specific requirements for manufacturers to ensure product quality and safety. These include the need for management commitment to quality, the establishment of a Quality Plan that defines how quality objectives will be met, and the identification and documentation of a Quality representative. However, contrary to the options provided, the QSR does not expressly require management to review the Quality System quarterly. Reviews must be conducted at defined intervals and are typically periodic, but the regulation does not stipulate a quarterly frequency.