QSR definition

QSR means the Quality System Regulation 21 of the Code of Federal Regulations, part 820, for the development and manufacture of medical devices and in-vitro diagnostic products.

QSR means FDA’s Quality System Regulation as set forth in 21 C.F.R. Part 820.

QSR means Quality System Regulation which describe 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, Code of US Federal Regulations, Part 820, as may be amended from time to time.

Examples of QSR in a sentence

• We will use NVivo software (QSR International, Inc.) for qualitative data storage and organization.

• The written and electronic record from QSR NVivo 10.0 of the coding scheme and interpretative processes used in the data analysis included all files and any changes made to the database.

• Among the two, QSR has been outpacing the market’s projected growth by 25%, making it one of the segments to watch.

• Margins remained under pressure as QSR deliveries fell below expectation and the business exited a major QSR account.

• This material, like any other properly issued rule, has the force and effect of law.9Instead of rewriting the QSR section by section to conform it to ISO 13485, FDA amended 21 CFR Part 820 so that it points to specific ISO 13485 content.

More Definitions of QSR

QSR means the Quality System Regulation, 21 C.F.R. Part 820, as may be amended from time to time and any successor thereto.

QSR means Quality System Regulation in the United States as promulgated by the FDA.

QSR means quick service restaurant.

QSR means 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.

QSR means quality systems regulation requirements related to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management for the manufacturing of Devices, as set forth in 21 CFR Part 820.

QSR means the Quality System Regulation promulgated by the FDA under the Act or other applicable regulatory agencies of countries in which the Commercial Product will be sold as of the time of manufacture of the applicable Commercial Products; including ISO 13485, the European Union Council Medical Device Directives (the "EU Medical Device Directives"), and the Quality System Regulations as described in 21 CFR Part 820.

QSR or "Quality System Regulations" means all applicable standards relating to manufacturing practices for medical devices promulgated by the FDA in the form of laws, regulations or guidance documents (including but not limited to advisory opinions, compliance policy guides and guidelines), and which guidance documents MTI knows or reasonably should have known to be applicable, current, feasible and valuable in ensuring device quality within the device manufacturing industry for such products in effect on the Effective Date or at any time thereafter during the Term.