The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
For the case of investigational devices, should give a signed statement, it should be stated that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
Masqué
CHEN Jieyun
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.
Ensure the PMS compliance and ensure the implementation of PMS activities.
The reporting obligations of reporting serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions and analysis of vigilance data are fulfilled.
Masqué
Cartographie de Shanghai Easy-Flow Medical Tech Co., Ltd
Personnes
CHEN Jieyun — Shanghai Easy-Flow Medical Tech Co., Ltd
WU Xiaowu — Shanghai Easy-Flow Medical Tech Co., Ltd
Catalogue de Shanghai Easy-Flow Medical Tech Co., Ltd