Registration of Medical Device

FDA registration

US market is probably the most desired goal for a Medical Device manufacturer.

Precise knowledge of FDA world can transform approval process in a quick and convenient way.

We offer such services:

  • US market: FDA Registration, Establishment Registration and Listing
    We manage all the process of registration Establishment and products on the US market, from Establishment Registration and Listing to 510(k)
  • US market: Design Control
    We assist companies in understanding and implementation of the Design Control according 21CFR820, necessary for the access to US market
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