In order to obtain the CE Certification, a Technical File is required, depending on the assessment procedure to be followed, as well as a Quality Management System by the manufacturer.
Di Renzo Regulatory Affairs is able to support the manufacturer throughout the whole procedure of certification of a device. In particular, we offer the following services:
- Feasibility studies related to the EC Certification project
- Preliminary assessment regarding the need to perform non-clinical and clinical testing on the MD
- Interaction with analysis laboratories, CROs and Notified Bodies
- Preparation of the Technical File
- Implementation of the quality system according to the standard ISO 13485
- Consultancy for the authorization of Borderline medical devices by Notified Bodies
- Consultancy for the certification of medical electrical equipment and medical software
- Certification of medical devices with OBL (Own Brand Labelling) procedure