Develop a Quality Management System $($QMS$)$ manual per $21$ CFR $820$ for a Class II medical device manufacturer. Manufacturers of medical devices must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA$-$regulated medical devices are known as current good manufacturing practices $($CGMP$$s$).$ CGMP requirements for devices in part $820(21$ CFR part $820)$ were first authorized by section $520($f$)$ of the Federal Food, Drug, and Cosmetic Act $($the act$).$ Under section $520($f$)$ of the act, FDA issued a final rule in the Federal Register of July $21,1978(43$ FR $31508),$ prescribing CGMP requirements for medical devices. This regulation became effective on December $18,1978$ and was codified under part $820.$

Please include the following seven $(7)$ subsystems in your Quality Management System $($QMS$)$ manual:

Management Subsystem

Corrective and Preventive Action Subsystem

Production & Process Control Subsystem

Documents, Records and Change Control Subsystem

Design Controls Subsystem

Materials Controls Subsystem

Equipment & Facility Controls Subsystem