To obtain the CE mark for medical devices and in vitro diagnostic medical devices (IVD), it is required the preparation of a technical dossier that includes a pool of information and regulatory applications, which range from project planning to risk analysis and post-marketing surveillance, with the aim of minimizing eventual risks deriving from their use.
We believe that in the same way as medicines, the world of medical devices requires an excellent knowledge of the relevant legislation and of the ISO standards that regulate them. We support companies in the delicate passage from Directive 93/42/EEC and 98/79/EC to Regulations 745/2017 and 746/2017with the aim of carrying out all the necessary activities required.
SCF provides regulatory solutions to Italian and foreign companies that produce, market and import medical devices of classes I, IIa, IIb, III and IVD, if they are producers, agents or for Own Brand Labeling (OBL), supporting them in the various phases of the process of CE marking.