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.
- EUDAMED.
- Review and apply for medical device advertising.
- Request for national code.
- Trainning sessions.
- Support for the implementation of the UNE-EN ISO 13485.
