CONSULTANCY FOR CE MARKING
Coronati Consulting carries out consultancy activities for the CE marking of Medical Devices in full accordance with the requirements of DDM 93/42 / EEC and European Regulation 745/2017 (MDR) for any type of class I, IIa, IIb and III device
The consultancy is carried out by personnel with specific preparation and experience acquired in multinational companies in the biomedical-pharmaceutical sector and subjected to the comparison of the most important Notified Bodies at national and international level.
The main consultancy activities for CE marking consist of:
-Technical file / technical documentation
-Risk management according to ISO 14971 with FMEA techniques for product and processes.
-Essential requirements checklist according to MDD and General Safety And Performance Requirements Checklist according to MDR.
-Clinical evalution report according to MEDDEV 2.7/1
-Interpretation and application of standards
-Identification and realizzation of qualification test of medical device and validation of critical processes.
-Assistance during the audit of the Notified Body
–Registration of medical device in the Italian ministry of Health database according to M.D: of 21/12/2009 and subsequent amendment.
-Support for medical device registration in Canada and USA (FDA)
-Assistance in post-market surveillance in case of incident or recall according European regulation requirements..
-Biological evaluation report according to ISO 10993-1
-Toxicological risk assessment according to ISO 10993-17