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Topic

    Sachi Mohanty
    eMDR transmission to FDA
    Topic posted March 14, 2019 by Sachi Mohanty, tagged Public Sector, Quality Execution, Tip, White Paper 
    139 Views, 2 Comments
    Title:
    eMDR transmission to FDA
    Summary:
    How companies comply with eMDR transmission tobFDA
    Content:

    client is medical device manufacturer and has to comply with this FDA requirement to file eMDR electronically to FDA. Any ideas on hiw this requirement was met in similar implementation?

    im sure our company is not the only one with this requirement. Any input would be much appreciated.

    Thank you. 

    Version:
    19A

    Comment

     

    • Gayle Hayes

      Hi Sachi,

      Thank you for your inquiry.   Traditionally we have had multiple partners provide solutions to customers for eMDR.  Inspirage has advised that they could assist with your request.  If you require contact info, please reach out to me at gayle.hayes@oracle.com and I'll make the introduction.

      best regards,

      Gayle

       

       

    • Elaine Wan

      In addition to Gayle's response, generating a Device History Record (DHR) based on a manufacturing work order and its transactions is planned for future roadmap. If you have any further questions, please let us know.

      Best regards,
      Elaine
      elaine.wan@oracle.com