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Gruppo Farmaimpresa addresses to all companies that manufacture, market or want to import Medical Devices providing support in:

  • Evaluation of conformity of technical documents and requirements for the registration of medical devices or preparing the same for obtaining the CE marking
  • Notification of medical devices in the ministerial database
  • Obtaining the CE marking and managing the relations with the Notified Body
  • The submission of clinical studies to the competent authorities, to the Ethics Committee and relative consulting activities.
  • Taking the role of QA / RA as defined by European regulation, to be adopted, for medical devices.
  • Taking the role of Mandatory (direct contacts with the competent authorities and management of post-marketing surveillance)
  • Second-type audits at companies and suppliers of medical devices in Italy and abroad with evaluation of the same
  • Implementation and eventual certification of quality system according to ISO 13485
  • Provision of training courses
  • Preparation of the documentation required for class I devices and technical statement issued by Gruppo Farmaimpresa
  • Preparation of advertising material and, if necessary, authorization request
  • Checking the prints of primary and secondary packaging
  • Design and realization of the primary and secondary packaging
  • Free sale certificates
  • Market surveillance

Moreover it can be a support in the realization of:

  • Clinical Studies
  • Clinical Trials
  • Drafting of the analysis and risks assessment
  • Stability tests according to ICH (International Conference on Harmonisation) for products containing substances