Officers and regulatory representatives of IDS France
VAILLANT Anne
Principal responsible for ensuing that :
- the conformity of the devices is appropriately checked, in accordance with the quality management system, 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
- the reporting obligations are fulfilled
- in the case of investigational devices, the statement referred to in the IVDR is issued.
Hidden
WILK Nathalie
Alternate person responsible for ensuing that :
- the conformity of the devices is appropriately checked, in accordance with the quality management system, 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
- the reporting obligations are fulfilled
- in the case of investigational devices, the statement referred to in the IVDR is issued.
Hidden
ROUSSEAU Céline
Alternate responsible for ensuing that :
(a) 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;
(b) the reporting obligations referred to in Articles 87 to 91 [Article 82 and 86 of the IVDR] are fulfilled;