Ensuring the technical documentation and the EU DoC are drawn up and kept up-to-date.
- Approval of CE IVD technical files
- Approval of EU DoC
Ensuring compliance to reporting of adverse events and field safety actions.
- Approval of adverse event reports
- Approval of field safety action reports
In the case of interventional clinical performance studies or other performance studies involving risk for the subjects, person that can sign a statement to the safety of the subjects.
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CARILLO Arlene
Ensuring the technical documentation and the EU DoC are drawn up and kept up-to-date.
- Approval of CE IVD technical files
- Approval of EU DoC
"Ensuring compliance to reporting of adverse events and field safety actions.
- Approval of adverse event reports
- Approval of field safety action reports
In the case of interventional clinical performance studies or other performance studies involving risk for the subjects, person that can sign a statement to the safety of the subjects.
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ARELLANO Minerva
Ensure post-market surveillance obligations are complied with in accordance with Article 10(9). - Approval of PMS plans - Approval of PMS reports - Approval of periodic safety update reports.
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BEOUGHER Cara
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.