Ottenuta la marcaura CE, l’azienda deve mettere in atto le attività finalizzate al suo mantenimento e al monitoraggio del prodotto sul mercato.
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).