Officers and regulatory representatives of DGS Diagnostics A/S
RATH Merete Djernæs
Ensuring that the conformity of the devices is appropriately checked in accordance with the quality management system under which the devices are manufactured, before a device is released, and for ensuring the post-market surveillance obligations are complied with in accordance with article 10(10) of the MDR 2017/745.
Ensuring that the reporting obligations referred to in Articles 87 to 91 of (EU) 2017/745 are fulfilled
Hidden
AMBIRK Mette
Ensuring that the technical documentation and declaration of conformity are drawn up and kept up to date, and that, in the case of investigational devices, the statement referred to in section 4.1 of chapter II or Annex XV of the (EU) MDR 2017/745 is issued.