产品与服务

Medical Device Contract Manufacturing is a Peiertech’s  joint venture business with Venta Medical in USA building the medical device which enhances lives of people. 

At Peiertech, we understand the life cycle of medical device, from the concept through a design, a development and into clinical trial and commercial productions.   Our team is consisted of a qualified people with the deep understanding and rich knowledge of design, engineering, and manufacturing processes of variety of different devices from a single use disposable to class I,II and III medical devices.   We helped our customers, both large and small, a shorter time for their market launch, reduce the risk and lower manufacturing cost and enhance their product quality.

We have a class 10,000 and 100,000 clean rooms and offer highest level of quality required for medical products.  Our quality system is registered to ISO 13485 and offer full process validation service per FDA QSR 21 CFR Part 820. 
From our design and manufacturing facility in US and in China,   we offer design for manufacturability analysis, plastic part design, material selection, rapid prototype , prototype injection molds for low cost design verification , sterile package design , shelf and shipping box design and configuration. 

Our process development and validation includes,  assembly process definition and design,  test procedure definition and design, tooling and fixture design and fabrication, equipment validations including I/Q, O/Q and P/Q, design of experiment, validation protocol development, testing and reports, sterile package seal strength characterization, sterilization validation, accelerated age studies and transit testing. 

To provide a single source solution, we will also provide a global sourcing, purchase, receive, inspect and stock components.  These parts then can be assembled, tested and packaged.  We will coordinate product sterilization, when required through certified contractors utilizing Gamma and Electron Beam irradiation as well as Ethylene Oxide gas processes. 

At Peiertech, our goal is to provide our customers with a complete range of contract manufacturing capabilities and we are constantly adding and improving our equipment and human resources.  We welcome the opportunity to work in partnership to help optimize your design for manufacturing and also to reduce the overall manufacturing cost.