Officers and regulatory representatives of Gardeslen Orthopaedie B.V.
GIJSEN Ramon
- the conformity of the devices is appropriately checked, in accordance with the quality management 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.