Choice One Medical Inc.

Shall ensure: (a) the conformity of the devices is appropriately checked in accordance with the QMS under which the devices are manufactured, before release; (b) the technical documentation and the EU DoC are drawn up and kept up-to-date; (c) the PMS obligations are complied with as in Article 10(10); (d) Reporting obligations referred to in Articles 87 to 91 are fulfilled; (e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.