Post-market surveillance obligations are complied with in accordance with Article 10(10).
Reporting obligations referred to in Articles 87 to 91 are fulfilled.
In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
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QUINONES Jessika
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.
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HESSABI Lisa
Reporting obligations referred to in Articles 87 to 91 are fulfilled. Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
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HOPPE Nicole
Post-market surveillance obligations are complied with in accordance with Article 10(10).
Reporting obligations referred to in Articles 87 to 91 are fulfilled.
In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.