Discussion: View Thread

  • 1.  CER

    Posted 14-Jan-2020 13:59
    Dear Colleagues, I am looking for consulting service to develop and create CER. Doe anyone have recommendation? Thank you.- Jin


  • 2.  RE: CER

    Posted 15-Jan-2020 09:11
    Hello!  We utilize RCRI (now Covence). They are very knowledgeable on EU MDR and rev 4 of the MEDDEV.

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    Melinda Smith MS, RAC
    VP, Quality and Regulatory Affairs
    Roswell GA
    United States
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    Original Message


  • 3.  RE: CER

    Posted 16-Jan-2020 09:29
    Thank you Melinda!​
    Original Message


  • 4.  RE: CER

    Posted 15-Jan-2020 12:24
    I recommend knoell. They are based in Germany and have the appropriate staff to compile a CER compliant to the MDR requirements. Turnaround time is great s well. https://www.knoell.com/en/business-units/medical-devices

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    Lacey Chessor RAC
    United States
    VP of Regulatory Affairs
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    Original Message


  • 5.  RE: CER

    Posted 20-Jan-2020 01:01
    Hi Jin,

    If you are looking for someone local, REGSolutions LLC, my company has been writing these to MDEDEV rev 4 for a few years now and have had great success passing NB reviews. We would be happy to assist.  Give me a call at 678-428-6978 or email to penny@pennynorthcutt.com  www.pennynorthcutt.com

    Thanks Penny
    Atlanta RAPS Chapter Leader

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    Penny Northcutt RAC, FRAPS
    President/CEO
    Santa Rosa Beach FL
    United States
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    Original Message


  • 6.  RE: CER

    Posted 16-Mar-2020 05:35
    Hi Jin,
    I trust you are going great. We are a Medical Device Engineering outsourcing company with extensive experience in Product Design and Quality Assurance. I would like to let you know that we have helped Medical Device companies to reduce their product cost by more than 40% with value engineering and innovative designs. We have deep experience in EU MDR and US FDA regulations and have completed 45+ CERs for class 1, 2a, 2b and 3 medical devices per MEDDEV 2.7/1 Rev 4. Please suggest if there are opportunities of collaboration with your great company. I will be happy to send more details.
    Thanks, 
    Kuldeep

    Founder & CEO
    Saraca Solutions Pvt. Ltd.



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    Kuldeep Tyagi
    Founder and CEO, Saraca
    Expert on EMDR, CER, FDA
    www.saracasolutions.com
    +1- 901-286-1890
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    Original Message