Contract Manufacturing of Medical Devices
The medical device contract manufacturing is high-mix-low-volume in nature. It requires adequate and skillful resources to carefully manage it. We have built a solid infrastructure and proficient team to support the complexity and dynamic nature of Class I and II medical device contract manufacturing services. Quality, Speed, Responsiveness, and Consistency are our specialty. We are a reliable partner you can always count on.
One of the main reasons we are able to deliver such high-quality medical device components is the fact that all production is done in-house. Controlling all stages of production eliminates our dependence on outside vendors and provides you the assurance of the single-source quality and reliability that is crucial to the medical industry. Our customers have peace of mind knowing that cleanliness levels and surface properties are verified.
- Customized medical machining
- Proven abilities in precision manufactured products
- Highest standard of production and quality control for medical device components
- Trained and experienced staff
- Manufacturing facility with “clean room ready” capabilities to handle your needs
- Design-for-Manufacturability engineering support to complement our machining and finishing operations
Leveraging Our Buying Power – Our engineers help customers find alternative parts to solve lead time problems and also help material cost to stay down. Our global procurement team can further help sourcing materials from other suppliers for cost reduction.
Maintaining Medical Device History Records – Eastek maintains medical device history records (DHR) in accordance with the requirements of the FDA regulations. Eastek’s Quality System ensures that DHR’s are maintained in accordance with the Device Master Record (DMR).
Best of Both Worlds (Speed & Cost) – Eastek provides responsive local quick-turn prototyping and low-to-medium production at our US facility in Milwaukee, WI, which helps you achieve faster “Time-to-Market”. When your volume achieves higher volume, we help you move production to a lower cost facility in Dongguan, China, which helps you to be more price competitive and increase your “Market Share”.
Eastek is an ISO 9001 & 13485 certified and FDA registered medical device contract manufacturing company. We have been a contract manufacturer of medical devices for more than 10 years. We are committed to maintaining full compliance in accordance with regulatory requirements.