Unisis Corporation

- Ensuring that the technical documentation and EU declaration of conformity are drawn up and kept up-to-date. - Ensuring that the PMS obligations are complied with in accordance with MDR Article 10(10). - Ensuring that the reporting obligations referred to in MDR Article 87 to 91 are fulfilled.

Ensuring that the conformity of the devices is appropriately checked in accordance with the QMS before devices are released.