Quality System Regulation or "QSR" shall mean the quality system requirements applicable to manufacturers of finished medical devices commercially distributed in the United States and its territories and possessions, codified at 21 C.F.R. Part 820.

Quality System Regulation means design control, Good Manufacturing Practices, and quality system management requirements governing the standards and methods to be used in, and the facilities or controls to be used for, the design, manufacture, processing, packaging, testing or holding of medical devices to assure their quality, safety, performance, and efficacy, including the FDA Quality System Regulation at 21 C.F.R. Part 820, international standards for quality management systems as adopted by the International Organization for Standardization such as ISO 13485:2016, and similar requirements of any Governmental Entity, as applicable.

Quality System Regulation means the Quality System Regulation under 21 C.F.R. Part 820.

Examples of Quality System Regulation in a sentence

The Company’s suppliers may encounter problems during manufacturing due to a variety of reasons, including failure to comply with applicable regulations, including the FDA’s Quality System Regulation, equipment malfunction and environmental factors, any of which could delay or impede our ability to meet demand.
Under an EUA, certain sections of the 21 CFR Part 820 Quality System Regulation (QSR) may be waived for an authorized product during the duration of the EUA, but FDA recommends that test developers follow comparable practices as much as possible.
Recipient: CuraeLase, Inc<br> Product:CL 1000 IR Laser System<br> Date: 12/9/2011<p> Quality System Regulation Concerns We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820): 6.

More Definitions of Quality System Regulation

Quality System Regulation has the meaning set forth in Section 3.23(b).

Quality System Regulation. ("QSR") shall have the meaning ascribed to it by the rules and regulations of the FDA, as may be amended or changed from time to time.

Quality System Regulation has the meaning set forth in Section 1.1.

Quality System Regulation or “QSR” is meant to include all applicable standards and requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices Products intended for human use, promulgated, enforced or endorsed by any Governmental Entity, or as otherwise required by applicable Laws, as in effect at the time of the Products manufacture.

Quality System Regulation shall have the meaning set forth in Section 2.3(a).

Quality System Regulation means the quality system regulation for medical devices, as defined in 21 C.F.R. Part 820, as amended from time to time, or a foreign equivalent thereof.

Quality System Regulation means the 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 CFR Part 820, and any applicable guidance document or standard published or recognized by the FDA.