Dirigeants et représentants réglementaires de PROHS SA
SILVA Luísa
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
Masqué
RODRIGUES Milton
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;
Masqué
Familles de dispositifs (UDI-DI de base) de PROHS SA