Regulatory Open Forum

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  • 1.  software validation consultant needed

    Posted 18-Aug-2016 19:17


    We are looking for an experienced software validation consultant for a Hayward, CA based company.  We are open to both on site or remote access.  Would prefer someone familiar with FDA requirements specific to a Class II device.  Please reach out with interest or references.

    Much appreciated :)

    Gretchen Upton RAC
    San Antonio TX
    United States

  • 2.  RE: software validation consultant needed

    Posted 19-Aug-2016 08:14

    Brian Shoemaker of Shoebar associates is very helpful.  Shoebar Associates

    Shoebar Associates remove preview
    Shoebar Associates
    ShoeBar Associates focuses on services related to software application and development for companies in the FDA regulated area (medical devices and diagnostics, biotechnology, pharmaceutical, and...
    View this on Shoebar Associates >
    Melissa Egan
    Senior Regulatory Affairs Specialist
    Waters Corporation
    Milford MA
    United States

  • 3.  RE: software validation consultant needed

    Posted 19-Aug-2016 09:46

    Currently, we are working with Syprosoft (located in CA), and they have been very good. My primary contact:

    Robert Lucero Director, Product Development & Compliance

    Syprosoft Engineering 1150 Main Street, Suite E, Irvine, California 92614, U.S.A.

    Phone: (949) 250-1065 ext. 110,  Fax: (949) 250-1075

    Web: www.syprosoft.comE-mail:

    Christina Talley MS, RAC, CCRP
    Program Director, Office of Strategic Research Initiatives
    Houston Methodist Research Institute
    Houston TX
    United States

  • 4.  RE: software validation consultant needed

    Posted 19-Aug-2016 11:43

    I'd highly recommend Tom Renner. or 541359.5939

    Brie Stoianoff
    Director of Quality and Service Assurance
    The FDA Group LLC
    Portland OR
    United States

  • 5.  RE: software validation consultant needed

    Posted 22-Aug-2016 11:06


    I can recommend RCRI services also.  You can contact Christine Lys who is based in CA,, for detailed information about our services.

    Carol Ryerson
    Regulatory & Clinical Affairs Director
    Minneapolis MN
    United States