The quality systems for fda regulated products food drugs biologics and devices are known as current good manufacturing practices cgmp s.
Fda quality management system requirements.
While regulatory imperative is the driving force behind the creation of a quality management system the qms is most certainly not a set of procedures that get stored on a hard drive only to be opened when inspectors arrive.
Is appropriate for the specific medical device s designed and or manufactured 2.
The fda worldwide quality system requirements guidebook for medical devices.
The requirements of good manufacturing practice are underpinned by a central objective.
To create a system of programs policies processes and facilities that prevent errors and defects.
Other device specific guidance documents prepared by cdrh for the medical device industry.
Meets the requirements of this part part 820 21 cfr 820 5 quality system 5.
With the requirements for quality systems.