ensuring that device conformity is supported by appropriate traceability within the Quality Management System (QMS); ensuring that the technical documentation and EU Declaration of Conformity are established, maintained and kept up to date; ensuring compliance with post-market surveillance and vigilance reporting obligations under the MDR; issuing the statement required under Annex XV, Chapter II, Section 4.1 for investigational devices; and signing the technical documentation.
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BURGUETE MANRIQUE Yolanda
ensuring that 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.
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CID MONTAÑES Cinta
- ensuring that the technical documentation and the EU Declaration of Conformity are drawn up and kept up to date.
- ensuring that the reporting obligations referred to in Articles 87 to 91 of Regulation (EU) 2017/745 are fulfilled.
- issuing the statement referred to in Section 4.1 of Chapter II of Annex XV in the case of investigational devices.
- signing the technical documentation