Location: Quang Minh IP, Me Linh District, Ha Noi City
Main scopes: Consulting ( 2017 ~ 2020)
– QSR ISO 13485 Training
– Validation Works including Coordination & Documentation
Authorities: PMDA (PIC/S, J-GMP)
Main Scopes: Engineering (05/2018 ~ 12/2019)
Build new factory to produce specific medical device
– Conceptual Design and Basic Design
– Cost estimation and bidding process support
– Project management
– Construction Observation;
– Validation Consultation as per PMDA request
Authorities: PMDA
