In the field of medical devices, Di Renzo Regulatory Affairs provides consulting services to Italian and foreign companies that produce, market and import Medical Devices & IVDs into the Italian territory.
It has a unit composed of three biomedical engineers, a chemist and administrative staff with over thirty years of experience in the field of Medical Surgical Devices and Medical Devices. It also collaborates with international experts able to provide normative and procedural support to companies interested in European and non-European markets.
The activities that this unit is able to perform relate to the following items:
- Advice on current legislation in Italy, Europe and in certain non-European countries in relation to medical devices.
- Verification of compliance of the technical documentation and the requirements for the registration of medical devices in Italy, Europe and in certain non-European countries
- Notification of medical devices into the database /Repertoire of the Ministry of Health and in the relative databases of other countries belonging to the EEA Agreement zone.
- Notification of in vitro diagnostic devices at the Ministry of Health and other European countries
- Registration of manufacturers of custom-made devices
- Preparation of technical dossiers in order to obtain the CE mark
- Contacts with Notified Bodies and consultancy for obtaining CE marking
- Contacts with qualified laboratories to conduct tests on devices
- Gap analysis on the documentation available from companies for marketing authorizations for devices in non-European countries
- Device-vigilance in Italy and Europe
- Assistance with the submission of clinical trials to the competent authorities and Ethics Committees, together with the related consulting activities.
- Assuming the role of QA / RA as defined by the forthcoming European Regulation on medical devices.
- Assuming the role of Authorized representative (direct contacts with the competent authorities of the EU and management of post-marketing surveillance)
- Regulatory activities regarding the import / export of medical devices
- Verification of compliance of the documentation accompanying medical devices for customs authorities
- Audits at companies and suppliers of medical devices
- Collaboration with and participation in the development of start-up projects in the biomedical field (feasibility studies).
- Implementation of the quality system in accordance with the ISO 13485
- Training Courses in European regulations and technical standards.
- Preparation of documents required for Class I devices and technical declarations of compliance issued by Di Renzo Regulatory Affairs
- Analysis of customs requirements and health and safety clearance (Nulla Osta Sanitario)
- Preparation of advertising material and, if necessary, the preparation of applications for authorization
- Certificates of Free Sale
- Preparation of technical reports required for registration of trademarks and product patents.