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    As Senior Director of Quality and Compliance at Yukon Medical she oversees the activities to maintain and enhance Quality Management System compliance with 21CFR Part 820 ISO 13485 and multiple ever changing international regulations for vial access and IV administration medical devices

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  • About the Yukon MedicalPreparation Drug Delivery

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  • Borla Inc Medical Device Supplier Directory

    A division of Borla Yukon Medical is an ISO 13485 certified and leading developer of innovative pharmaceutical preparation and delivery devices with a focus on reconstitution at the point of care and injectable drug delivery These include our ViaLok Non Vented Vial Access devices ViaLok Vented Vial Access devices Arisure Closed

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  • List of countries that require ISO 13485 certification

    Because ISO 13485 has gained significant recognition around the world in this article we will discuss how the requirements of the standard are applicable to manufacturers of medical devices in different countries What is the worldwide situation considering the obligations of ISO 13485 Europe panies active in the EU market are expected to have a Quality Management System

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  • Genie Closed Vial Access Device CLAVE Clave

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  • NewsPrimaPharma

    PrimaPharm Announces Successful ISO 13485 2003 Recertification Audit March 15 2013PrimaPharm Inc a contract manufacturer of drugs and medical devices announces the successful completion of its ISO 13485 2003 recertification audit for its production facility located in San Diego California PrimaPharm has maintained its ISO 13485

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  • ISO 13485 Quality Management System for Medical Devices

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    EP A2 VIAL ACCESS AND INJECTION SYSTEM origin WOA2 A device for mixing and transferring is described The device comprises a housing having open ends a container accessing member having at least one fluid conduit therethrough the container accessing member extending generally outwardly from one end of the housing

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    SKU 1SCA SLX33 4 This kit contains four rolls of blank white labels for the Codonics Safe Label System SLS model SLS 500i Using the SLS the syringe label information prints automatically from a barcode scan of the drug vial and preparation information Each roll of labels contains 1000 labels They are used in the Codonics SLS 500i for