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Why MediMark Europe should be your choice?

  • Because we are certified to ISO 9001:2015 specifically for our activity of European Authorized Representative.
    Notification of your files to the European Data Bank (MD and IVD) through the French Competent Authority), Incident analysis, Reporting, Recall, Technical file review and maintenance, etc, are under quality system. Our customers may include controlled copies of our procedures directly in their own quality system.
  • Because we are the first European Company of Regulatory Affairs which has set up the standards of Authorized Representative’s activities in early 1995, after discussion with Competent Authorities.
    After 22 years devoted to the activity of Authorized Representative for US Manufacturers, our professionalism is highly recognized by the European Competent Authorities, by the Notified Bodies, and of course by our customers.
  • Because we provide our customers with a comprehensive package of documents to help them for building their Technical Files and they may phone us for assistance._ Our customers can ask us also by phone or e-mail any question concerning European Regulatory Affairs. It is common that they send us an e-mail late afternoon and they receive the answer for the next morning. We maintain an update large database of regulatory documents including EN Standards to better serve them. The European office can be reach by phone up to 11:00 PM (European Time) 365 days per year.
  • Because in case of incident, we work very closely with you and with your distributor to make the analysis. If reportable, we write the initial and final reports and always submit them to you for eventual corrections and approval before we send to the concerned Competent Authority.
  • Because we offer you the guarantees of the highest level of confidentiality, no change in our European Address and a solid financial structure.
  • Because we offer fair rates for such responsibilities.

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