Having built medical tools for many years, we decided to focus our molding operation on manufacturing medical device components and in 2019, certified our Quality Management System to ISO 13485:2016. In 2020, we registered with the FDA as a Medical Device Contract Manufacturer. During that time, we added key personnel to support this transition and have continued to grow ever since.
From product conception, through Design for Manufacturing (DFM), prototyping, validation, and into finished good manufacturing, we never lose sight of those principles. We utilize an IQ, OQ, PQ approach to validating new projects, developing a robust molding process to consistently yield acceptable product, while meeting agreed upon capabilities at a range of operating conditions. As needed, we can also customize a validation strategy to meet specific customer requirements
From traditional horizontal molding, to overmolding, insert molding, and vertical molding – we provide custom molding solutions for your most challenging components. The use of integrated automation allows us to minimize manual interactions, in turn maximizing our productivity while ensuring part consistency and lot control.
We’ve partnered with industry-leading molding machine and auxiliary equipment suppliers, allowing us to develop the best custom molding solution for your project.
We have an unwavering commitment to support our customers and the patients who depend on them. By utilizing advance planning for raw material supply and production, we safeguard against delays, ensuring product gets where it’s needed most. With a 99% on time delivery performance, it’s more than just a number – it’s the way we do business.
