SEPTODONT

Ensures that the obligations relating to Vigilance activities and notifications to Health Authorities and Notified Bodies are fullfiled.

Ensures that: - compliance of the devices is properly checked, in accordance with the quality management system under which the devices concerned are manufactured, before a device is released; - the manufacturer applies and updates a post-marketing surveillance system in accordance with regulation 2017/745.

Ensures that: - The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date - In the case of investigational devices, the statement that the device in question conforms to the general safety and performance requirements with the exception of the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject