Officers and regulatory representatives of Illumina Netherlands B.V.
RODRIGUES CARDOSO Rute
Responsible for ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; the post-market surveillance obligations are complied with; the reporting obligations are fulfilled; in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in IVDR Section 4.1 of Annex XIV is issued.
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MEDLEY Vicky
Responsible for 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; the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; the post-market surveillance obligations are complied with.