Unik Surgical Sutures Mfg. Co.

Article 15 as follows: the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; the TD and the EU DOC are drawn up and kept up-to-date;the 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.