PROHS Equipamento Hospitalar e Serviços Associados S.A.

a) Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; b) Ensure the post-market surveillance obligations are complied with in accordance with Article 10(10) of MDR; c) Ensure that reporting obligations referred to in Articles 87 to 91 of MDR are met for: • Serious incidents; • Field Safety Corrective Actions (FSCA) • Trend Reporting • Analysis of serious incidents • Analysis of FSCA • Analysis of vigilance data

a) Ensure 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; b) Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;