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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • The Distributor agrees to maintain appropriate records of the distribution of all Product(s) consistent with the information requirements described in the United States Food and Drug Administration’s Medical Device Reporting Regulations and applicable sections of the United States Food and Drug Administration’s Quality Systems Regulations (21 Code of Federal Regulations 820, sections 820.140, 820.150, 820.160), or any applicable future (replacement) regulations.

  • Any new facility proposed to be used by Qualigen in manufacturing any Product shall be subject to a new and separate audit by Sekisui personnel in accordance with Quality Systems Regulations (QSR), as well as ISO 13485.

  • Distributor will comply with Quality Systems Regulations in connection with reporting to Halozyme any product complaints regarding the Product.

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 Standardization 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 Schedule.

  • Water quality standards means provisions of state or federal law which consist of a designated use or uses for the waters of the Commonwealth and water quality criteria for such waters based upon 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) and the federal Clean Water Act (33 USC § 1251 et seq.).

  • UCITS Regulations means the European Communities Undertakings for Collective Investment in Transferable Securities) Regulations, 2011 (S.I. No. 352 of 2011) (as amended consolidated or substituted from time to time) and any regulations or notices issued by the Central Bank pursuant thereto for the time being in force.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • National Ambient Air Quality Standards or “NAAQS” means national ambient air quality standards that are promulgated pursuant to Section 109 of the Act, 42 U.S.C. § 7409.

  • Interconnection Regulations means the Telecommunication (Broadcasting and Cable) Services Interconnection (Addressable Systems) Regulations, 2017 (as amended).

  • Benchmarks Regulation means Regulation (EU) 2016/1011 of the European Parliament and of the Council of 8 June 2016 on indices used as benchmarks in financial instruments and financial contracts or to measure the performance of investment funds and amending Directives 2008/48/EC and 2014/17/EU and Regulation (EU) No 596/2014;

  • Conduct Regulations means the Conduct of Employment Agencies and Employment Businesses Regulations 2003;

  • Accessibility Standards means accessibility standards and specifications for Texas agency and institution of higher education websites and EIR set forth in 1 TAC Chapter 206 and/or Chapter 213.

  • ERCOT Protocols means the document adopted by ERCOT, including any attachments or exhibits referenced in that document, as amended from time to time, that contains the scheduling, operating, planning, reliability, and Settlement (including Customer registration) policies, rules, guidelines, procedures, standards, and criteria of ERCOT. For the purposes of determining responsibilities and rights at a given time, the ERCOT Protocols, as amended in accordance with the change procedure(s) described in the ERCOT Protocols, in effect at the time of the performance or non-performance of an action, shall govern with respect to that action.

  • Safety Standards means all laws, union rules and trade or industry custom or codes of any kind whatsoever, in effect from the date of this Agreement through Final Acceptance of the construction work, pertaining to worker safety and accident prevention applicable to the Project and/or the construction work (including, but not limited to, rules, regulations and standards adopted pursuant to the Occupational Safety and Health Act of 1970, as amended from time to time).

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • CDM Regulations means the Construction (Design and Management) Regulations 2015;

  • SAFE Rules and Regulations means collectively, the Circular 37 and any other applicable SAFE rules and regulations.

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • PDMA means the Prescription Drug Marketing Act, as amended, and the rules and regulations promulgated thereunder.

  • TRADES Regulations means the regulations of the United States Department of the Treasury, published at 31 C.F.R. Part 357, as amended from time to time. Unless otherwise defined herein, all terms defined in the TRADES Regulations are used herein as therein defined.