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  • 1.  EU Authorized Representative in Germany

    This message was posted by a user wishing to remain anonymous
    Posted 02-May-2023 07:56
    This message was posted by a user wishing to remain anonymous

    Hello,

    We are looking for an EU Authorized representative to replace our current one, preferably in Germany so that the transition will be easier from our current registrations.
    Does anyone have any references?



  • 2.  RE: EU Authorized Representative in Germany

    Posted 02-May-2023 15:09

    You could reach out to Dennis Brussies from Brussies Life Sciences:

    http://brussies-ls.com/



    ------------------------------
    Michael Hottner
    Köln
    Germany
    ------------------------------

    Original Message


  • 3.  RE: EU Authorized Representative in Germany

    Posted 03-May-2023 00:58

    Hi,
    There is a list of EAAR members at this link:
    https://www.eaarmed.org/members/

    Among them are colleagues based in Germany together with other reputable consultants offering Authorised Rep services.
    Good luck!



    ------------------------------
    Claire Murphy ASQ-CQA, Eng
    Partner and Consultant at Tecno-med Ingenieros
    Barcelona
    Spain
    ------------------------------

    Original Message


  • 4.  RE: EU Authorized Representative in Germany

    This message was posted by a user wishing to remain anonymous
    Posted 03-May-2023 07:53
    This message was posted by a user wishing to remain anonymous

    mdi Europa GmbH is located in Germany and offers services as an EU AR for IVDR and MDR:

    https://mdi-europa.com/


    Original Message


  • 5.  RE: EU Authorized Representative in Germany

    This message was posted by a user wishing to remain anonymous
    Posted 03-May-2023 07:53
    This message was posted by a user wishing to remain anonymous

    Our company has MDSS as our EU Authorized Rep for ~ 20years and highly recommend them. Have never had an issue with them.


    Original Message


  • 6.  RE: EU Authorized Representative in Germany

    Posted 03-May-2023 10:30

    We a 90 person company in Medical Imaging under EU MDR and have used MDSS Germany and also use them for UK and Swiss no issues
    https://mdssar.com/



    ------------------------------
    Barry Welenc
    Director, Quality & Regulatory
    La Grange IL
    United States
    ------------------------------

    Original Message


  • 7.  RE: EU Authorized Representative in Germany

    Posted 03-May-2023 11:03

    Dear Barry,
    thank you for recommending MDSS.  Greatly appreciated!
    Dear Anonymous.  Thank you for the high recommendation. Also greatly appreciated!

    Dear Anonymous seeking for an AR.  Please contact me (l.moeller@mdssar.com) directly and our team is happy to support you.



    ------------------------------
    Ludger Moeller
    President, MDSS GmbH
    l.moeller@mdssar.com
    ------------------------------

    Original Message


  • 8.  RE: EU Authorized Representative in Germany

    Posted 04-May-2023 04:43

    Dear Anonymous,

    Another German member of EAAR is MT Promedt Consulting GmbH, which can take over the function of Authorised Representative and can also support you in the preparation of Technical Documentation, Clinical Evaluations and your QM system. 

    If you have any questions, please feel free to contact me directly.
    (mohr@mt-procons.com)

    Clemens Mohr
    MT Promedt Consulting GmbH





    ------------------------------
    Clemens Mohr
    St. Ingbert
    Germany
    ------------------------------

    Original Message


  • 9.  RE: EU Authorized Representative in Germany

    Posted 04-May-2023 07:18

    If it is for medical device, we use the following, located in Hamburg, Germany:

    Dental Contact Vertriebs KG

    Dental- & Medizinhandel

    Im Spiet 101

    D 26506 Norden / Ostfriesland

    Telefon +49 (0)4931 9809681

    E-Mail:    info@dental-contact.de

    Internet: www.dental-contact.de



    ------------------------------
    Tim White
    RA Manager
    Orchard Park NY
    ------------------------------

    Original Message


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