Officers and regulatory representatives of Mt Ortho
COMUNALE DAMIANO
the technical documentation and the EU declaration of conformity are drawn up and kept up to date;
the post-market surveillance obligations referred to in Article 10, paragraph 10, are fulfilled;
the reporting obligations referred to in Articles 87 to 91 are fulfilled;
Hidden
DI GRAZIA Teresa
the compliance of the devices is properly checked in accordance with the quality management system under which the devices are manufactured before release; in the case of devices under investigation, the declaration referred to in Annex XV, Chapter II, point 4.1, is issued.