Medical device manufacturing requires adequate and skillful resources. To answer that call, we have built a solid infrastructure and a dedicated team to support the complexity and dynamic nature of Class I and II medical device manufacturing services. Because of our commitment to quality, speed, responsiveness, and consistency, our customers are able to rely on us as a trusted partner.
Having all production done in-house allows us to deliver high-quality medical device components at competitive prices. Because we can control all stages of production we are able to eliminate our dependence on outside vendors and assure customers the single-source quality and reliability that we know is crucial to the medical industry. Our customers have peace of mind knowing that we verify cleanliness levels and surface properties as well.
- 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.