Officers and regulatory representatives of Bioitech
LEONARDIS Mauro
Conformity of devices is appropriately checked in accordance with the QMS. The tech. documentation and the EU d.o.c. are drawn up and kept up-to-date; PMS 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