Regulatory compliance under Article 15 of the IVDR (EU) 2017/746. This includes: the conformity of the device, in accordance to the quality management system under which it is manufactured, the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date, post-market surveillance obligations are complied with in accordance with Article 10(9), the reporting obligations referred to in Articles 82 to 86 are fulfilled.
Summary: PRRC and Quality Management Officer