Medical Devices - Supplements - Cosmetics

Opening Hours : Monday to Friday - 8am to 12pm and 15pm to 19pm
  Contact : Tel. +39 053598377 Cell. +39 3284598580

Medical Device Consulting Services

How we can help you to ensure your compliance with all European regulations?

 Our consulting services for MD (Medical Devices) and IVD (In Vitro Diagnostic Medical Devices) compagnie:

  • Regulatory Affairs
  • Technical File Compilation
  • Medical Device Certification
  • Registration Services
  • Clinical Evaluation Reports (CER)
  • ISO 13485 – 17025 Implementation
  • Validation Services
  • Audit Services

We also offer In-depth Feasibility Studies, Market Entry Strategy, Risk Management and Usability Engineering, Organisation of Clinical Trials in Italian Hospital Facilities and the new Classification of the Medical Device.