PROTOTYPING

We realize your concept by prototyping

We make prototypes from customers’ preliminary requirements through a professional process.
 

Our prototyping service

During the product development process, after we have re-confirmed that the concepts and ideas of the projects can be realized into products, our R&D and engineering team would then provide our customers with our engineering designs, and development solutions and take lead to realize their concept into medically-approved end products. Our R&D and engineering team would stay in close collaboration with our customers to modify and update the designs based on their feedback, producing prototype products for their approval so that we can continue to develop new products and refine existing products to meet their evolving needs.

Generally under the CDMO business model, once the prototype product has been approved by our customers, we will then collaborate with them to proceed with the clinical trial and registration prior to the mass manufacturing stage. During the process of clinical trial and registration, we would collaborate with our customers in the  verification and validation process in obtaining FDA or similar regulatory approvals for the medical devices by preparing the necessary documents for customers’ submission to the relevant authorities.