With regard to this sector, Di Renzo Regulatory Affairs has set up a unit for medical device consulting consisting of two biomedical engineers, a pharmacist and an administrative employee, with more than twenty years of experience in the field of  MSAs and Medical Devices.

The activities that this unit is able to offer are essentially the following:

• Consultancy for the importation of medical devices
• Advice on current Italian, European and non-European legislation
• Requests for free sale certificates
• Notification, with the authority of the manufacturer, of medical device into the Database / Directory of the Ministry of Health as provided for by the Ministerial decree of the 21 December, 2009
• Revision of advertising material and the submission of authorization applications to advertise
• Drafting and / or review of technical dossiers for obtaining CE Certification
• Consultancy for the authorisation of Borderline medical devices at Notified Bodies
• Consultancy for the preparation of quality systems according to ISO 13485: preparation of quality manuals and the necessary (SOP) procedures
• Compilation of clinical evaluations from literature
• Device vigilance activities
• Consultancy regarding clinical trials
• Design and creation of mock-up of primary and secondary packaging
• Refresher training company corse

The languages spoken by our company, apart from Italian, are English, German, French, Spanish and Chinese