Quality Systems Regulations definition

Quality Systems Regulations means current quality systems regulations for medical products, as promulgated by the FDA, and the requirements thereunder imposed by the FDA, or any more stringent standards required by Applicable Laws, including without limitation the regulations set forth in 21 C.F.R. Part 820 and equivalent Canadian Applicable Laws.
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Quality Systems Regulations or "QSR" shall mean all applicable standards relating to manufacturing practices for the Product promulgated by the U.S. FDA in the form of laws or regulations.
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Quality Systems Regulations means the good manufacturing practices and design control requirements for medical devices set forth by Applicable Laws, including United States 21 C.F.R. Section 820.
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Examples of Quality Systems Regulations in a sentence

  • GP shall perform all of its manufacturing obligations under this Agreement in accordance with all FDA requirements including the Quality Systems Regulations as set forth in 21 C.F.R. 820, "good laboratory practices," and "good clinical practices" to the extent applicable, and GP's own standard operating and quality control standards and applicable industry-wide standards for proper laboratory procedures and practices.

  • TheraSense will manufacture, design and --------------------------- label FreeStyle Products for the U.S. Territory in accordance with the then governing U.S. FDA Quality Systems Regulations, and for the European Territory in accordance with the then governing European Union Quality Systems Regulations.

  • ArthroCare will manufacture Licensed Products in accordance with ISO 9000 Standards, EN 46000 Standards, FDA Quality Systems Regulations (including Current Good Manufacturing Practices), and requirements of the Medical Device Directives ("MDD") and the then-current product specifications, as may be modified from time to time by the mutual written consent of the parties hereto.

  • All Company Devices manufactured by the Company or which the Company causes to be manufactured by third parties are manufactured in accordance with applicable Quality Systems Regulations, 21 C.F.R. Part 820.

  • STRATEC shall design and develop the Instrument in accordance with international regulatory requirements, (EN ISO 13485:2003 and ISO 9001 (2008)) including in particular, the then current Quality Systems Regulations (“QSR”) as established by the United States Food and Drug Administration in accordance with GMPs covering devices regulated by each FDA Center governing the intended use of the Instrument, i.e., diagnostic testing).

  • The premises and equipment used to manufacture the Product shall be maintained according to the standards outlined in ISO 13485:2003 (Quality Management Standard for Medical Devices), ISO 14971 (Risk Management System), Annex I Essential Requirements of the Medical Device Directives 93/42/EEC and Sub-Chapter H, Part 820 of Title 21 of the United States Code of Federal Regulations (Quality Systems Regulations for Medical Devices), in each case, as may be amended from time to time.

  • In order for Halozyme to comply with Quality Systems Regulations (QSR’s) as promulgated by FDA and other regulatory authorities, Distributor must report to Halozyme any product complaints regarding the Product, within fourteen (14) days of the Distributor being informed of such complaint.

  • SiTech shall at all times operate the Texas Facility and manufacture its products in conformance with ISO-9002 and current Good Manufacturing Practices Quality Systems Regulations (the "GMPs"), as promulgated by the United States Food and Drug Administration.

  • Avail warrants that all Products distributed in the U.S. shall be manufactured in accordance with the Quality Systems Regulations ("QSR") of the U.S. Food and Drug Administration (hereinafter "FDA"), or any new or revised standards imposed by that agency, in a facility that is registered with the FDA.

  • All design, development and manufacturing operations performed by or on behalf of Seller are being conducted in material compliance with the Quality Systems Regulations of the FDA (21 C.F.R. Part 820), Good Manufacturing Practices at 21 C.F.R. 210, 211, and, to the extent applicable to Seller, counterpart regulations in the European Union and all other countries where compliance is required.

Related to Quality Systems Regulations

  • Quality System means documented organizational procedures and policies: internal audits of those policies and procedures: management review and recommendation for quality improvement.”

  • Quality Standards means the quality standards published by BSI British Standards, the National Standards Body of the United Kingdom, the International Organisation for Standardisation or other reputable or equivalent body, (and their successor bodies) that a skilled and experienced operator in the same type of industry or business sector as the Contractor would reasonably and ordinarily be expected to comply with, and as may be further detailed in the Specification.

  • Water quality standards or "WQS" means provisions of state or federal law that consist of a designated use or uses for the waters of the Commonwealth and water quality criteria for such waters based on such uses. Water quality standards are to protect the public health or welfare, enhance the quality of water, and serve the purposes of the State Water Control Law (§ 62.1-44.2 et seq. of the Code of Virginia), the Act (§ 62.1-44.15:24 et seq. of the Code of Virginia), and the CWA (33 USC § 1251 et seq.).

  • UCITS Regulations means the European Communities (Undertakings for Collective

  • Applicable water quality standards means all water quality standards to which a discharge is subject under the federal Clean Water Act and which has been (a) approved or permitted to remain in effect by the Administrator following submission to the Administrator pursuant to Section 303(a) of the Act, or (b) promulgated by the Director pursuant to Section 303(b) or 303(c) of the Act, and standards promulgated under (APCEC) Regulation No. 2, as amended.