Genomtec Spółka Akcyjna

ensuring the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; ensuring the technical documentation and the EU DoC are drawn up and kept up-to-date; ensuring that the PMS obligations are complied with in accordance with Article 10(9) of Regulation (EU) 2017/746; ensuring that the reporting obligations referred to in Articles 82 to 86 of the Regulation (EU) 2017/746 are fulfilled;