Officers and regulatory representatives of Bio-Rad
FERNEZ Sylvie
- Drawing up and keeping up-to-date of the technical documentation and the EU declaration of conformity
- Fulfilling the reporting obligations referred to in Articles 82 to 86
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CARTIER Laetitia
- Appropriately checking of the conformity of the devices , in accordance with the quality management system under which the devices are manufactured, before a device is released
- Compliance of the post-market surveillance obligations with in accordance with Article 10(9)
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MASSON Christine
- Issuance of the the statement referred to in Section 4.1 of Annex XIV , 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