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Medical Devices and In Vitro Diagnostics

In the field of medical devices (MDs) and in vitro medical diagnostics (IVDs), Di Renzo Regulatory Affairs provides Italian and foreign companies manufacturing, marketing, exporting and importing these products with consulting services, thus providing assistance to all economic operators involved. It has a unit made of highly qualified technicians with a long experience in this sector.

The main services offered are:

  • Feasibility studies and Regulatory Intelligence for medical devices
  • Consultancy on Technical Dossiers and CE marking
  • Consultancy on the marketing and post-marketing phase
  • Quality Management System according to ISO 13485
  • Free Sale Certificates
  • Medical device promotion
  • Clinical trials of medical devices
  • Post-market surveillance
  • Assuming the role of UK Responsible Person (UK RP)

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