Ensure 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.
Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
Ensure the post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR.
Ensure the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled.
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MARIAN Ben
Ensure 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.
Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
Ensure the post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR.
Ensure the reporting obligations referred to in Articles 87 to 91 of the MDR are fulfilled.