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
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.