FDA Quality System Regulations definition

FDA Quality System Regulations means the regulations of the U.S. Food and Drug Administration applicable to the methods and documentation of the design, testing, production, control, quality assurance, labeling and packaging of the M2ATM Capsule.
Sample 1

Examples of FDA Quality System Regulations in a sentence

  • Manufacturer(s) shall conform to the quality standards set by the International Organization for Standardization and/or the US FDA Quality System Regulations.

  • Manufacturer shall conform to the quality standards set by the International Organization for Standardization and/or the US FDA Quality System 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.

  • Similarly, a dose margin of 60- fold (based on body weight) for embryo-fetal development is estimated using the NOAEL (also the highest dose tested in Study 117250) following repeated SC injection in mice compared with the maximum dose to be administered to patients [47].

  • The Company and its Subsidiaries, or an agent of the Company or its Subsidiaries, manufactures each product of the Company and its Subsidiaries in material compliance with each device master record (as such term is defined in the FDA Quality System Regulations) maintained by the Company and its Subsidiaries, or an agent of the Company or its Subsidiaries, for each product of the Company and its Subsidiaries.

  • In order to better meet the requirements of regulatory bodies including:ñ FDA Quality System Regulations as set forth in 21 CFR PART 820,ñ Labeling instructions outlined in 21 CFR Part 810,ñ Canadian Medical Device Regulations (SOR/98-282),ñ EU Medical Device Directive (MDD 93/42/EEC),ñ And other applicable regulatory bodies A-M Systems has established documented, implemented and maintains a quality management system in accordance with the requirements of the ISO 13485:2016 Standard.

  • In addition, IUCF was responsible for the design and construction of the Proton Therapy System and as such is required to follow FDA Quality System Regulations for medical device manufacturers.

  • Thus a full quality system satisfying both the requirements of the U.S. FDA Quality System Regulations and the EN ISO 13485:2016 should be exercised to enable access to both markets.

  • Except as set forth in Section 4.11 of the Disclosure Schedule, all operations of the Business (a) are compliant, in all material respects, with all applicable FDA Quality System Regulations and FDA Establishment Registration and Listing requirements and (b) have achieved and maintained all applicable quality certifications including all required ISO (International Organization for Standardization) certifications.

  • KNC represents and warrants to Synthes that the Products and other items furnished hereunder will be manufactured in accordance with the applicable approved Specifications and FDA Quality System Regulations (QSR), and ISO 13485:2003 or equivalent.

Related to FDA Quality System Regulations

  • 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.

  • 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.).

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

  • Ambient air quality standard means an established concentration, exposure time, and frequency of occurrence of air contaminant(s) in the ambient air which shall not be exceeded.

  • 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.

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

  • 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.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • 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.

  • High Quality Waters means all state waters, except:

  • the 2000 Regulations means the Water Supply (Water Quality) Regulations 2000(b); "the 2001 Regulations" means the Water Supply (Water Quality) Regulations 2001(c);

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

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

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

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

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Spatial Planning and Land Use Management Act means the Spatial Planning and Land Use Management Act, 2013 (Act 16 of 2013);

  • Licensed clinical social worker means an individual who meets the licensed clinical social worker requirements established in KRS 335.100.

  • Market Abuse Regulation means Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse;

  • 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.

  • the 1997 Regulations means the Zebra, Pelican and Puffin Pedestrian Crossing Regulations 1997.

  • 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.

  • Water quality volume means the volume equal to the first one-half inch of runoff multiplied by the impervious surface of the land development project.

  • Development regulations or "regulation" means the controls

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.