SEMDATEX GmbH

Ensuring that (a) the conformity of the devices is checked under the QMS before release; (b) the technical documentation and EU declaration of conformity are drawn up and kept up to date; (c) the post-market surveillance obligations are complied with (Art. 10(10)); (d) the reporting obligations are fulfilled (Arts. 87–91). [MDR Art. 15(3)]

Ensuring that (a) the conformity of the devices is checked under the QMS before release; (b) the technical documentation and EU declaration of conformity are drawn up and kept up to date; (c) the post-market surveillance obligations are complied with (Art. 10(10)); (d) the reporting obligations are fulfilled (Arts. 87–91). [MDR Art. 15(3)]