Medical devices

TIARE CONSULTING S.L. offers the following regulatory services to manufacturers, importers or distributors of medical devices:

  • Elaboration of a medical device dossier (class I, IIa, IIb, III and in vitro).
  • Elaboration a medical device dossier with a medicinal substance.
  • Support for CE certification. Support and strategy advice with Notified Body.
  • CER (clinical evaluation report) and PER (performance evaluation report) elaboration.
  • Management medical device surveillance and elaboration:
    • Clinical evaluation plan (CEP).
    • PMS (Postmarket surveillance).
    • PMCF (Postmarket clinical follow-up).
    • PSUR (Periodic safety update report).
  • Application for a medical device manufacturing or importing licence.
  • Application for notification of distribution of medical devices.
  • Registration of the person responsible for the medical device.
  • Communication of marketing and/or putting into service, modifications or cancellations of products.
  • Review and apply for medical device advertising.
  • Request for national code.
  • Trainning sessions.
  • Support for the implementation of the UNE-EN ISO 13485.