Quality System Regulations definition

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.

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Quality System Regulations means Part 820 of Title 21 of the Code of Federal Regulations.

Quality System Regulations or “QSRs” means 21 C.F.R. Part 820 which sets forth the cGMP requirements that govern the methods used in, and the facilities and controls used for, designing, Manufacturing, packaging, labeling, storing, installing, and servicing of medical devices intended for human use, or the equivalent Law as required by an FDA Counterpart.

Examples of Quality System Regulations in a sentence

As used herein, “GMP” means current good manufacturing practices, including without limitation the FDA’s Quality System Regulations pursuant to Title 21 of the United States Code of Federal Regulations, Part 820, as applicable to the manufacture of a Class 2 medical instrument to gain 510(k) approval by the FDA.
Comply with the pertinent Quality System Regulations ("QSR") as such may be determined by the FDA and all applicable United States government regulatory requirements.
Submit to periodic quality audits; TheraSense's Quality Assurance department may, at its sole option, perform audits of Facet's compliance with Quality System Regulations, with the quality control requirements specified herein and attached hereto as Exhibit C, together with any other quality systems and specifications mutually agreed upon.
Each party shall possess a Quality Assurance System that adheres to applicable laws, rules, and regulations, including without limitation the practices and regulations of the FDA (including without limitation the applicable sections of the current Quality System Regulations as expressed in 21 C.F.R. Part 820 and Pre-Market Notification Procedures of 21 C.F.R. Part 807, Subpart E).
All Products subject to FDA Laws are designed, manufactured, processed, packaged, tested, distributed and held in material compliance with the applicable requirements of the FDCA and other FDA Laws, including but not limited to applicable current good manufacturing practice requirements under the Quality System Regulations (“QSR”) in 21 CFR Part 820.
As used herein, “GMP” means current good manufacturing practices, including without limitation the FDA’s Quality System Regulations pursuant to Title 21 of the United States Code of Federal Regulations, Part 820, as applicable to the manufacture of a Class [2] medical instrument to gain 510(k) approval by the FDA.
The Components will be designed and manufactured by ANALOGIC in a manner that will qualify and validate all manufacturing processes in accordance with current Good Manufacturing Practices and the Quality System Regulations promulgated by the United States Food and Drug Administration (“FDA”) and ISO 9001 and for the Components after July 2002.
LAKE REGION agrees to comply with the current revisions of: ◦ USA 21 CFR 820 Quality System Regulations ◦ ISO 13485 LAKE REGION will obtain and maintain product regulatory clearances in the USA, including FDA 510k clearance.
Lake Region warrants that it will manufacture the Product in accordance with current Quality System Regulations (“QSR”) for medical devices as mandated by the FDA and in compliance with International Standard ISO 13485 and with any and all other applicable federal, state and local laws, rules, and regulations.
ANALOGIC further warrants that all of the Components sold to TOMOTHERAPY under this Agreement will, on the date of shipment by ANALOGIC, have been manufactured by ANALOGIC in accordance with the FDA’s current Good Manufacturing Practices, Quality System Regulations, ISO 9001.

More Definitions of Quality System Regulations

Quality System Regulations is defined in Section 4.16(b)(ii).

Quality System Regulations means all current 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) including current good manufacturing practices ("cGMP"), provided that with respect to any discretionary guidance documents, ICU knows or reasonably should have known that such guidance documents are applicable, currently feasible and valuable in ensuring device quality within the device manufacturing industry for such Products.

Quality System Regulations means the codification of Good Manufacturing Practices for medical devices by the FDA as set forth in 21 C.F.R. Part 820.