We can accompany you from the beginning to obtain the CE mark and manage all the obligations that will follow, including supervision.
We can also follow you in the complex transition to the new European Regulation. We are authorised European representatives and can help you to import and verify the conformity of the medical devices you wish to distribute in the EU.
We can make your life easier in the management of ISO 13485 and ISO 9001 quality systems, in the implementation of organisational models in accordance with Legislative Decree 231/2001 and in participation in public procurement, including the electronic marketplace MEPA.
In the Repertory of Medical Devices of the Ministry of Health we have registered more than 30 thousand medical devices of all kinds and classes, in a few days we can assign a repertory number to the products you manufacture or distribute.
We organize training courses that can qualify your employees and make you autonomous in the areas of Quality, Regulatory Affairs and Public Procurement.
We have a lot of experience and we put it at your disposal to unlock the commercial potential of your products.
Company’s Keywords:
regolamento 2017745, marcatura ce, gare dappalto, iso 13485, iso 9001, dlgs 2312001, repertorio dispositivi medici, consulenza regolamentare dispositivi medici
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