Regulatory Open Forum

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  • 1.  Contract Complaint Handling Company

    Posted 05-Jun-2020 18:06
    I am looking for a good contractor who provides services to medical device companies for complaint handling, including receipt, documentation, and customer follow-up.  Of course, their processes must be solid and meet 21CFR Part 802 and ISO13485 requirements.  My company will work with the contractor in the complaint investigation, but wants to work with a contractor in the process rather than establishing in-house capabilities.  Any recommendations???

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    Gary Turner RAC
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  • 2.  RE: Contract Complaint Handling Company

    Posted 07-Jun-2020 08:13
    Hi Gary 
    Let us connect to discuss further. Please reach out at your convenience. Thank you.

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    Naveen Agarwal
    Jacksonville FL
    United States
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  • 3.  RE: Contract Complaint Handling Company

    Posted 08-Jun-2020 14:30
    Hi,

    I have a similar situation and would like to join the conversation and network with you on this topic.  My contact information is below.

    Thank you in advance for your consideration.






  • 4.  RE: Contract Complaint Handling Company

    Posted 09-Jun-2020 02:32
    Hi Gary,

    At my company, we are currntly working on this with a couple of clients. especially now that so many EUAs are requiring this. Feel free to reach out to me!

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    Isabella Schmitt, RAC
    Regulatory Affairs Consultant
    Houston TX
    United States
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  • 5.  RE: Contract Complaint Handling Company

    Posted 09-Jun-2020 11:08
    Edited by Eileen Quinn 09-Jun-2020 12:10
    I have good experience with Innomar Strategies. Please feel free to reach out with questions.

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    Virginia Anastassova RAC
    RA Manager, Senior QA Specialist
    Victoria BC
    Canada
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  • 6.  RE: Contract Complaint Handling Company

    Posted 10-Jun-2020 07:02
    At my former company we used Safety Call and found them to be very good. Happy to talk with you about our experience with them.

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    Ann Gaitan
    VP of Regulatory Affairs & Compliance
    Charlotte NC
    United States
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  • 7.  RE: Contract Complaint Handling Company

    Posted 10-Jun-2020 15:28

    Thanks, Ann, for the recommendation.  I will check them out.

     

    Gary

     






  • 8.  RE: Contract Complaint Handling Company

    Posted 10-Jun-2020 17:25

    Thanks, Ann.  I have reached out to them for more information.

     

    Gary