Biotechni S.A.S

According to the article 15 of the MDR 2017/745, Marina MAKEENKO is 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 in accordance with Article 10(10); - The reporting obligations referred to in Articles 87 to 91 are fulfilled; - In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

According to the article 15 of the MDR 2017/745, Laura ANDRAWOS is 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 reporting obligations referred to in Articles 87 to 91 are fulfilled.

According to the article 15 of the MDR 2017/745, Franck OLIVERA is 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.