The QSR requires medical device packaging that protects devices during handling and shipping, and from the environment and microorganisms until the packaging is opened. This includes allowing for any necessary sterilization. Packaging may contain integral labeling and instructions for use or these instructions may be in a manual or package insert. Finally, when the consumer is ready to use this product, the package should be easy to open without compromising the quality of the device. When a controlled environment is necessary to prevent abnormal deterioration of a product, the environment should be specified, controlled, and monitored according to specifications in the device master record.
Installation requires verification that the device meets acceptance criteria.
The QSR requires manufacturers to review, evaluate and, when appropriate, investigate complaints. Manufactures must establish and maintain written procedures describing the process used to perform these activities and designate a responsible individual or entity to perform these tasks. The intent of the quality system regulation is to assure that servicing is correctly performed and verified according to company specified requirements such that the serviced device is suitable for the intended use and that service information is collected and analyzed to help correct any quality system problems and device design, manufacturing, labeling, or packaging problems. The QSR requires that a documented independent inspection and review of a quality system be performed on a periodic basis in accordance with written procedures. The objective is to verify, by examination and evaluation of objective evidence, the actual degree of compliance with those elements of the quality system under review.