Graas Orthopedische Schoentechniek B.V.

- 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 declaration custom made device 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