BUILDING 17-7-1, JINNAN AVENUE
ROOMS 101–108, SHENBAO INDUSTRIAL PARK, EAST ZONE, JINNAN ECONOMIC DEVELOPMENT ZONE, JINNAN DISTRICT, TIANJIN, CHINA
300350 TIANJIN
CHINA
1. Ensure device compliance with EU regulations before market release;
2. Prepare and update technical documentation and EU Declaration of Conformity;
3. Oversee post-market surveillance (PMS) and handle complaints/incidents;
4. Fulfill reporting obligations (e.g., serious incidents, FSCA);
5. Issue statements for investigational devices.