QualiMEDtech helps worldwide non-European medical device manufactures for getting CE Marking certificate by providing support in preparing the technical file or design dossier, Identifying the harmonized standards, drafting the mandatory ISO 13485:2016 procedures, conducting Clinical Evaluation as per MEDDEV 2.7.1 Rev 4 and European Authorized Representative Service.

All non-European manufactures intended to sell Medical Device in Europe by affixing CE Mark Logo on the product must apply for CE Certificate with a Notified Body after making an agreement with Authorized Representative CE Marking or authorized representative from Europe.

Our main features.

  • We have offices in USA and India in addition to our head office in Bremen Germany. This helps us to reach anywhere in Asia pacific and Americas.
  • Our experience in handling various Risk class of devices (Class 1,11a,11b, 111)
  • We help clients by providing Free Sale Certificate.
  • European Authorized Representative (EAR) or European Representative CE Marking Service contracts will be done mush faster and more economical then others.
  • Good working relationship with various medical device notified Bodies helps clients to communicate with them much faster to get CE Marking process complete faster.

Contact us for the bespoke EC Representative Services and technical solutions for Medical Device CE Marking.

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