Vitalitec International, Inc.

b) the technical documentation and the EU Declaration of Conformity prepared and maintained up to date; c) obligations regarding post-market surveillance, in accordance with Article 10, paragraph 10; d) Obligations regarding notifications referred to in Articles 87 to 91 e) In the case of investigational devices, declaration referred to in Annex XV, Chapter II, Section 4.1.

a) the compliance of the devices properly verified, in accordance with the quality management system under which the devices concerned are manufactured, prior to the release of any device