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.
Masqué
MARTINEZ Raquel
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.
Masqué
DEVELTER Joanna
In the case of investigational devices, a statement that the ID is in conformance with the GSPRs apart from the aspects covered by the investigation, is issued.
Masqué
WALSH Darren
The post-market surveillance obligations are complied with in accordance with the MDR PMS requirements. The reporting obligations for vigilance are fulfilled.