Officers and regulatory representatives of MacroMedics
DRENTH Jaap
- 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;
- The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
Hidden
HAJÓS Elizabeth
- The post-market surveillance obligations are complied with in accordance with Article 10(10);
- The reporting obligations referred to in Articles 87 to 91 are fulfilled