BAAT Medical Products B.V.

The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date, The post-market surveillance, The conformity of the Medical Device is checked (before delivery) in accordance with the QM-system, The reporting obligations referred to in Articles 87 to 91 MDR are fulfilled, In the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued