Medical Device Contract Manufacturing is Peiertech major business.
We manufacture devices that save and enhance people's lives.
At Peiertech, our goal is to provide our customers with a comprehensive, turnkey contract manufacturing capabilities and to constantly add and improve our capabilities and human resources. We welcome the opportunity to work in partnership to help optimize your design for manufacturing high-precision minimally-invasive medical devices while improving quality and yield, and also reducing the overall manufacturing cost and delivery time.
We understand the life cycle of medical devices, from the concept, design, development, V&V and into the clinical trial and post-market commercial productions. Our team consists of qualified experts with a deep understanding and knowledge of the design, engineering, and manufacturing processes of a variety of different devices from single-use disposable class I, class II, and class III devices to implantable class III medical devices. We helped our customers, both large and small, a shorter time for their market launch, reduce the risk and lower manufacturing costs, and enhance their product quality.
We have a GMP-certified class 10,000 and class 100,000 clean rooms and ensure the highest level of quality required for medical products. Our quality system is registered to ISO 13485 and offers full process validation service.
From our manufacturing facility China (near Shanghai), 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 include assembly process definition and design, test procedure definition and design, tooling, and fixture design and fabrication, equipment validations including IQ, OQ, PQ, design of experiment, validation protocol development, testing and reports, sterile package seal strength characterization, sterilization validation, accelerated aging studies and transit testing.
To provide a single-source solution, we will also provide global sourcing, purchase, receive, inspection, 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 (EtO) gas processes.