EmCyte Corporation

ensuring the conformity of the devices are appropriately checked in accordance with the quality management system the company uses before devices are released; ensuring that technical documentation and the EU declaration of conformity are drawn up and kept up to date; ensuring that post-market surveillance obligations are complied with Article 10(10) of the EU MDR (2017/745); and the reporting obligations are complied with Articles 87-91 of the EU MDR *2017/745).