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.
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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.
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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.

  • 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.

  • 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.

  • The demonstrated manufacturing capability will be in compliance with ISO 13485 standards as well as the Quality System Regulations at 21 CFR Part 820.

  • 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.

  • 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.

  • MTI shall be solely responsible for compliance with all Quality System Regulations affecting the Products, including, at a minimum, International Standards Organization ("ISO") certification and compliance with FDA Quality System Regulations.

  • The Company and the Subsidiary are in compliance in all material respects with the FDA's registration and listing requirements to the extent required by applicable Law, and the Existing Products, if so required, have been manufactured in all material respects in accordance with the Good Manufacturing Practice requirements in the FDA Act and the Quality System Regulations promulgated by the FDA, and are in conformance in all material respects with all applicable CE Marking certifications.

  • Class II devices are subject to additional controls, including full applicability of the Quality System Regulations, and requirements for 510(k) pre-market notification.


More Definitions of Quality System Regulations

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

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

  • 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.).

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

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

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

  • 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.

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

  • 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.

  • 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.

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

  • 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;

  • 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.

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

  • ISA Regulations means The Individual Savings Account Regulations 1998, as amended or replaced from time to time.

  • 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;

  • Data Protection Regulation means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 20161 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation);

  • 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).

  • Market Abuse Regulation means the EU Market Abuse Regulation (596/2014).