Quality improvement model also known as the PDCA cycle. Model consists of 4 steps: Plan, Due, Check, and Act. These steps are repeated to form a continuous cycle.

The compilation of records that describes the design history of a finished device. It includes the design activities used to develop the device, major components, accessories, labeling, production, and packaging. A DHF is required for every device or group of devices that are manufactures according to a DMR.

These records should show that all of the specifications outlined in the DMR are accomplished for all the manufactured devices. This is an FDA requirement for medical device manufacturers.

Records compilation for a device. These records contain specifications for the: production process, device, quality assurance, packaging, labeling, installation, maintenance and service procedures.