Quality System Regulation definition

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

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

Examples of Quality System Regulation in a sentence

• 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.

• Manufacturing devices in accordance with the Current Good Manufacturing Practices Quality System Regulation in 21 CFR Part 820.

• Imagin will ensure that the i/Blue Imaging System will be in compliance with the requirements of the FDA’s Quality System Regulation, ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes, and additional international compliance requirements.

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 means design control, Good Manufacturing Practice, 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 and associated FDA guidance, 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 Authority.

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 or "QSR" means the regulatory requirements for the methods used in, and the facilities and controls used for, the design, manufacture, packing, labeling, storage, installation and servicing of finished devices, codified at 21 C.F.R. Part 820. ​

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

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.