The vigilance unit for medical devices, set up by Di Renzo Regulatory Affairs, is part of a wider vigilance unit, which also covers the field of medicinal products for human and veterinary use (pharmacovigilance), biocides, cosmetics and food supplements. Di Renzo Regulatory Affairs has a technical group, which includes a physician, a chemist, a pharmacist, a biologist, an administrative employee, and it is able to offer to its clients the following services:

• Managing the reporting of adverse incidents or close call events
• Follow-up of adverse incidents or close call events
• Compilation of reporting forms for the competent authority
• Contact with Companies, Local Health Authorities and Ministry of Health
• Role of responsible person or local responsible person for vigilance
• Cooperation with companies in the preparation of SOPs
  Refresher training company courses