Ultimate Solution Experts (USE) can provide the auditing and consulting services for the Quality System Regulations implementation that are applicable quality system requirements, as amended from time to time, for the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use according to any applicable guidance document or standard published or recognized by the different regulatory authority of the different countries.

The regulation requires that various specifications and controls be established for products or devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality management system; that finished devices meet these specifications; that devices be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Thus, the Quality System regulation helps assure that medical devices are safe and effective for their intended use.