Regulatory Open Forum

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  • 1.  CER Writer

    Posted 26-Dec-2023 14:23

    Can anyone recommend a CER Writer for a non-invasive, low-risk, Class IIa device that utilises non-ionising radiation? 



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    Rebecca Tucek
    Melbourne FL
    United States
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  • 2.  RE: CER Writer

    Posted 27-Dec-2023 00:46
    Edited by Karthik Natesan, RAC 27-Dec-2023 00:47

    Hello Rebecca - I'll be happy to assist you with writing a CER for Class IIa device. Feel free to reach out to me at kn@knconsultingandservices.com

    We can discuss more about the CER over a zoom call.

    Thanks



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    Karthik Natesan, RAC
    KN Consulting and Services
    (Quality and Regulatory Consultant)
    Palm Beach Gardens, FL
    P: 949-245-5607
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    Original Message


  • 3.  RE: CER Writer

    Posted 28-Dec-2023 01:12

    Hi Rebecca,

    Happy to help.
    Please write to me at: aj@i3cglobal.com

    Thank you.



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    ASHA JOHNSON
    Regulatory Affairs Consultant (Device compliance - EU)
    I3CGLOBAL, India
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    Original Message


  • 4.  RE: CER Writer

    Posted 28-Dec-2023 11:46

    Hello Rebecca,

    ComplianceAcuity can do this for you using one of our experienced CER writers.  Our CER writers have written many successful CERs and include specialists with organic Notified Body CER experience.  We'd be glad for the opportunity to do you CER(s).  Feel free to reach out to me for further information.

    Best regards,

    Kevin

    kevin@complianceacuity.com



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
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    Original Message


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