Regulatory Open Forum

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  • 1.  In need of a 3rd party Internal Quality Auditor

    Posted 06-Nov-2013 08:26


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    John Newman
    Omega Medical Imaging
    Sanford FL
    United States
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    Can anyone recommend an Internal Quality audit service for a Medical Device Manf. in Central Florida?
    Must be certified to audit CAN/CSA-ISO 13485:2003. Required for end of Nov. early Dec. 2 day audit.


  • 2.  RE:In need of a 3rd party Internal Quality Auditor

    Posted 11-Nov-2013 12:01
    Hi John,

    I recommend Regulatory Compliance Associates, Inc (RCA).  I am in Rx and OTC product manufacturing and recently worked with a QA auditor from this firm.  They do have a location in FL, either Tampa or St. Petersburg. 

    http://www.rcainc.com/

    Good Luck!

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    Alison Trado
    Coordinator, Regulatory and Quality Affairs
    Wellspring Pharmaceutical Corporation
    Sarasota FL
    United States
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