Once CE marking has been obtained, the company has to set up activities for its maintenance, including the monitoring program of the product on the market.
For this we support the company implementing an adequate system of management of device’s vigilance system, and relative standard operating procedures (SOP) that include a plan of eventual corrective action. Moreover, we can also manage the registration of the manufactures and medical devices in the Database of the Ministry of Health, and the management of eventual modifications, as well as the preparation of the request of Certificates of Free Sale (CFS).