Officers and regulatory representatives of Pruis Orthopedie B.V.
EVERS Dennis
- The comformality of the device is appropriately checked, in accordance with the quality mangement system under which the devices are manufactured, before a device is released;
- The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- The post-market-surveillance obligations are complied with in accordance with Article 10;
- The reporting obligations regarding vigilance are fulfilled.