ISO 13485 definition

ISO 13485 means the “ISO Quality Management Systems — Medical Devices — System Requirements for Regulatory Purposes” standard.
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ISO 13485 means the “ISO Quality Management Systems - Medical Devices - System Requirements for Regulatory Purposes” standard.
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ISO 13485 means the international standard, adopted by the International Standards Organization, which concerns the quality systems applicable to manufacture of medical devices. "XXXXXXX & XXXXXXX CLAIM" shall have the meaning set forth in Section 2.02(g).
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Examples of ISO 13485 in a sentence

  • The product must be ISO 13485 compliant.Substantiation: The bidder must submit and attach to the bid response, a copy of a valid certificate.

  • Product brochure or technical data sheet(s) of the equipment showing the technical specifications in English Language.2. Valid and current Certificate of Compliance of manufacturer of the equipment with the latest version of ISO 13485: Quality Management System – Requirements for regulatory purposes in the name of the manufacturer.

  • For U.S. companies which wish to distribute their products outside the U.S., UTMD’s maintenance of certification to current ISO 13485 medical device quality standards is an important benefit.

  • In addition to any of the Medical Device warranties provided under this Agreement, you warrant that you operate a Quality Management System that complies with the requirements of ISO 9001 or ISO 13485.

  • Manufacturer and Supplier should have ISO 13485 certification under ISO 9001for quality standards.

  • Zeltiq shall establish and maintain an ISO 13485 compliant quality system for the design and manufacture of the Products and shall comply with the obligations listed in Exhibit B of this Agreement.

  • All personnel involved in ISO 13485 certification shall meet the competency requirements of Annex B.

  • The Company also evaluates each existing and each new supplier generally on an annual basis and gives each supplier an internal score which is in line with internal quality management systems regarding ISO 9001, EN 9100, ISO 13485 and ISO 140001.

  • If the certification of a quality management system was requested for the manufacturer of medicinal products pursuant to DIN EN ISO 13485 or a quality assurance system in accordance with Annex II, V or VI of the 93/42/EEC directive, the "Zertifizierordnung Managementsysteme” also apply.

  • MD.4.4.1 ISO 13485 requires the organization to comply with the statutory and regulatory requirements applicable to the safety and performance of the medical devices.


More Definitions of ISO 13485

ISO 13485 means the 2003 or 2016 edition of the publication ISO 13485, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes, published by the International Organization for Standardization;
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ISO 13485 means the International Organization of Standardization’s standard that represents the requirements for a comprehensive quality management system for the design and development, manufacture, installation and servicing of medical devices.
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Related to ISO 13485

  • ISO-NE means ISO New England, Inc. or any successor entity.

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

  • 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.

  • HITECH means the Health Information Technology for Economic and Clinical Health Act.

  • 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).

  • NERC Reliability Standards means the most recent version of those reliability standards applicable to the Generating Facility, or to the Generator Owner or the Generator Operator with respect to the Generating Facility, that are adopted by the NERC and approved by the applicable regulatory authorities, which are available at xxxx://xxx.xxxx.xxx/files/Reliability_Standards_Complete_Set.pdf, or any successor thereto.

  • cGLP means the current good laboratory practice regulations promulgated by the FDA, published at 21 C.F.R. § 58, and all applicable FDA rules, regulations, orders and guidances and equivalent or comparable non-United States regulations, rules, orders, guidances and standards in the Territory, as applicable, as such current laboratory practices, rules, regulations, orders, guidances and standards may be amended from time to time.

  • 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.

  • 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.

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

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

  • 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.).

  • ISO-NE Rules means all rules and procedures adopted by NEPOOL, ISO-NE, or the RTO, and governing wholesale power markets and transmission in New England, as such rules may be amended from time to time, including but not limited to, the ISO-NE Tariff, the ISO-NE Operating Procedures (as defined in the ISO-NE Tariff), the ISO-NE Planning Procedures (as defined in the ISO-NE Tariff), the Transmission Operating Agreement (as defined in the ISO-NE Tariff), the Participants Agreement, the manuals, procedures and business process documents published by ISO-NE via its web site and/or by its e-mail distribution to appropriate NEPOOL participants and/or NEPOOL committees, as amended, superseded or restated from time to time.

  • 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.

  • Environmental, Health, and Safety Requirements means all federal, state, local and foreign statutes, regulations, and ordinances concerning public health and safety, worker health and safety, and pollution or protection of the environment, including without limitation all those relating to the presence, use, production, generation, handling, transportation, treatment, storage, disposal, distribution, labeling, testing, processing, discharge, release, threatened release, control, or cleanup of any hazardous materials, substances or wastes, as such requirements are enacted and in effect on or prior to the Closing Date.

  • NISPOM means the National Industrial Security Program Operating Manual.

  • 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;

  • PCI DSS means the Payment Card Industry Data Security Standard, issued by the Payment Card Industry Security Standards Council, as may be revised from time to time.

  • NYSRC Reliability Rules means the rules applicable to the operation of the New York Transmission System. These rules are based on Reliability Standards adopted by NERC and NPCC, but also include more specific and more stringent rules to reflect the particular requirements of the New York Transmission System.

  • Safety Requirements means Prudent Electrical Practices, CPUC General Order No. 167, Contractor Safety Program Requirements, and all applicable requirements of Law, PG&E, the Utility Distribution Company, the Transmission Provider, Governmental Approvals, the CAISO, CARB, NERC and WECC.

  • Federal safety requirements means applicable provisions of 49 U.S.C. § 30101 et seq. and all

  • Guide dog means a guide dog as defined in section 1 of the Blind Persons’ Rights Act

  • MARPOL 73/78 means the International Convention for the Prevention of Pollution from Ships (1973) as modified by the Protocol of 1978 relating thereto;

  • Program Requirements means certain minimum program entry requirements as well as ongoing program requirements, to be fulfilled by Partner, some of which are general PartnerEdge requirements, some of which are specific for the “Sell Engagement” and some of which are specific for the different “Cloud” Product Families, including, without limitation payment of the Program Fee(s), meeting certain minimum annual revenue requirements, upholding a Sell Authorization for at least one “Cloud” Product Family and other requirements as set out in detail in the PartnerEdge Program Guide and the RSPI.

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

  • CLIA means the Clinical Laboratory Improvement Amendments of 1988 or any successor statutes.