The Quality System regulation are promulgated under section 520 of the Food, Drug and Cosmetic (FD&C) Act. They require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The regulation requires that various specifications and controls be established for devices; that devices be designed under a quality system to meet these specifications; that devices be manufactured under a quality 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 QS regulation helps assure that medical devices are safe and effective for their intended use. The FDA monitors device problem data and inspects the operations and records of device developers and manufacturers to determine compliance with the requirements of the Quality System Regulation.

The QS Regulation is contained in Title 21 Part 820 of the Code of Federal Regulations. This regulation covers quality management and organization, device design, buildings, equipment, purchase and handling of components, production and process controls, packaging and labeling control, device evaluation, distribution, installation, complaint handling, servicing, and records.

QUALITY SYSTEM DEVELOPMENT

Push-Med can help you develop an FDA compliant quality system or bring your existing QS up-to-date. From creating SOP’s to in-house personnel training, we can assist you through every step of your QS growth.

PREPARATION FOR FDA INSPECTIONS

In preparation for an FDA inspection, we will visit your facilities and perform a mock FDA inspection. We will perform on-site reviews of your internal systems as well as prepare your staff for any questions they might be asked.