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  • 1.  One for one initiatives

    Posted 16-Sep-2019 13:53
    Hello, 

    I was wondering if anyone here has ever worked with a company that donates devices to developing countries. I'd be curious to hear about your experience and what regulatory registrations etc. you determined were necessary to be in place before donating the devices. 

    Thank you, 

    Michelle


  • 2.  RE: One for one initiatives

    Posted 18-Sep-2019 09:58
    Hi Michelle,

    Its second party knowledge for me. But you do need to know the respective countries regulations. Have you tried to contact Doctors Without Borders or another worthy healthcare organization?  Non-GMOs  procure supplies for their activities across the globe. 

    The FDA requires that the product must  be within dating to ship. 


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    Carol Cooper RAC
    Principal
    Libertyville IL
    United States
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    Original Message


  • 3.  RE: One for one initiatives

    Posted 19-Sep-2019 09:47

    Michelle,

    Reach out to Maritza Moncayo at IRIS Global.  She helped me donate devices to several countries a few years ago.  She is a seasoned regulatory professional, specializing in countries in Latin / South America.  She also has good connections and may be able to help you as well.

     

    Regards,

    Yvonne DeBartolo

    Senior Director, Global Strategies and Compliance

    Global Regulatory Affairs

    Transfusion and Cell Technologies Division

     

    Fresenius Kabi

    Three Corporate Drive

    Lake Zurich, IL 60047

    Office : +1 847 550 7954

    Mobile : +1 224 358 8940

    E-mail : yvonne.debartolo@fresenius-kabi.com

    www.fresenius-kabi.com

     




    Original Message