Officers and regulatory representatives of TEKNIMED SAS
SALLES Stéphanie
- Person responsible for ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
- Person 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.
- Person responsible for ensuring that the reporting obligations referred to in Articles 87 to 91 of MDR (EU) 2017 /745 are fulfilled.
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VAN DE MOORTELE Solange
- Person responsible for ensuring that the post-market surveillance obligations are complied with Article 10(10) of MDR (EU) 2017/745.
- Person responsible for ensuring that for investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.