Questo sito utilizza cookies tecnici per il corretto funzionamento. Leggi

Device vigilance

Di Renzo Regulatory Affairs is able to offer its clients the following services:

  • Assuming the role of Responsible Person for Vigilance at a national and European level; contact point with the competent Authorities of the various European and non-European authorities
  • Assistance with the formalities required by European legislation in the event of incidents in EU and non-EU territories (Handling of notifications of incidents / near misses)
  • Assistance to manufacturer / authorized representative during the follow-up phase of incidents and near misses
  • Refresher courses for company staff
  • Preparation of the quality system, preparation of internal Standard Operating Procedures (SOPs) and audits
  • Continuous availability