Dirigeants et représentants réglementaires de ACUOTECH EGYPT. LTD
1 contact identifié
SADEK Mohamed
Ensure devices are designed and manufactured in compliance with MDR requirements before release
Ensure the EU Declaration of Conformity (DoC) is correctly drawn up and maintained
Ensure Post-Market Surveillance (PMS) system is established, implemented, and maintained
Ensure preparation and updating of PMS reports / PSUR (as applicable to device class)
Ensure vigilance reporting (serious incidents and FSCAs) is carried out in accordance with MDR timelines