The following diagram shows the general development phases of our medical devices CDMO solutions project, which our Taiwan headquarter mainly handles the project management and product design and our production facility at Kunshan, the PRC handles the mass production.
* For CDMO projects, the clinical trial and registration is handled by our CDMO customers with us providing DHF and other technical support
When our customer approaches us for CDMO solutions in the design, development and production of medical devices such as component development of new products or enhancement of existing products, we would form a cross-department project team to manage the project. Our operation process typically consists of five phases, namely,
• concept study
• design transfer/clinical trial and registration (for our self-developed products)
• mass production