Sychem Ltd

PRRC responsibilities are to: 1. Check the conformity appropriately, in accordance with the applicable QMS, before release; 2. the technical documentation and the EU DOC are drawn up and kept up-to-date; 3. the PMS obligations are complied with in accordance with Article 10(10); 4. the 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.