Spain | Consulting

Your consulting services partner in Spain

We offer strategic and customized solutions to meet international regulations and enhance the success of your products in global markets.

At CMC Consulting, we provide consulting services on the latest regulations and technical documentation preparation.

CMC will guide you through every step of obtaining CE marking for medical devices and in vitro diagnostic devices under the new regulations (MDR 2017/745 and IVDR 2017/746) to achieve CE marking for your device. We can also assist with conducting clinical trials in the EU for medical devices and IVDs.

EU FSC

A Free Sale Certificate, sometimes referred to as an “Export Certificate,” is proof that medical devices are legally sold or distributed in the open market, freely and without restrictions, and approved by regulatory authorities.

It is used when registering a new product in a non-European country. CMC can also apply for the EU FSC (Free Sale Certificate) for any country worldwide, including country-specific legalisation.