Quality System Regulation definition

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

Examples of Quality System Regulation in a sentence

  • As to each product or product candidate of the Company or any of its Subsidiaries subject to FDA regulation or similar legal provision in any foreign jurisdiction, all manufacturing facilities of the Company and its Subsidiaries are operated in compliance with the FDA’s Quality System Regulation requirements at 21 C.F.R. Part 820, as applicable, except where such non-compliance, individually or in the aggregate, would not have a Material Adverse Effect.

  • ISO 27001:2013 (Information Security Management) or FDA’s Quality System Regulation, etc.

  • Quality System Regulation The Quality Management System is applicable to the design, manufacture, administration of installation and servicing of magnetic resonance imaging scanner systems.

  • The FDA also can require the manufacturer to cease marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.Our manufacturing processes are required to comply with the FDA’s Good Manufacturing Practice, or GMP, requirements contained in its Quality System Regulation, or QSR.

  • This is a repeated violation of the Quality System Regulation as listed in the Warning Letter issued to your firm on May 7, 2008.


More Definitions of Quality System Regulation

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 or “QSR” means the requirements applicable to manufacturers of finished medical devices (including design control and current good manufacturing practices) pertaining to 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, as specified in 21 C.F.R. Part 820 and FDA’s guidance documents, and all applicable successor regulations and guidance documents thereto.
Quality System Regulation has the meaning set forth in Section 1.1.
Quality System Regulation means, collectively, Quality System Regulation under 21 C.F.R. Part 820.
Quality System Regulation or “QSR” means the FDA’s quality system requirements applicable to manufacturers of finished devices, codified at 21 C.F.R. Part 820.
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.