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Medical Device Establishment Registration Services In Europe
2 services found
by:Endo Endoengineering Srl based inFalconara Marittima, ITALY
The DM 21 December 2009 establishes the obligation to register in the medical devices database uses new methods. Registration is mandatory for all manufacturers and other entities responsible for placing devices on the Italian market for Class I, IIa, IIb and III, kits and assemblies and active implantable ...
by:KombiMED GmbH based inDortmund, GERMANY
Approval of medical devices in the Commonwealth of Independent States. Since the approval of medical devices in the Commonwealth of Independent States (CIS) is based on a separate product test, approval procedures for European companies are often a challenge. European product certificates (CE and FDA) are not recognised and are partially ignored. The approval procedure consists of several steps ...