Fulfilling or delegating all of the following responsibilities for the Allendale and Leesburg campuses, including ensuring: - 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 post-market surveillance obligations are compiled in accordance with Article 10 (10); - The reporting obligations referred to in Articles 87 to 91 are fulfilled.
Masqué
EGGLETON Justin
Fulfilling or delegating all of the following responsibilities for the Allendale and Leesburg campuses, including ensuring: - the technical documentation and the EU DOC are drawn up and kept up-to-date; - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.