Medical Contract Manufacturing Services
The world’s largest medical product, technology and services OEMs partner with us to manufacture life saving medical parts and devices. We are on several industry-leading Approved Supplier Lists.
We engineer and manufacture products that are regulated by the FDA including 510(k), and class I and class II devices. We assist in preparing and compiling data for your FDA submission.
Offshore Capabilities & Supply Chain Management
Our overseas manufacturing experience helps to reduce cost. We understand the advantages and complexities of offshore manufacturing and exercise complete supply chain management.
Clean Room Molding
Our facilities feature a class 8 (100,000) clean room for molding and assembly of medical devices and parts. In addition we also have a clean room for silicone (LSR) molding.
We are ISO 13485:2012 and ISO 9001:2008 certified, ITAR and FDA registered.
Our team of quality engineers ensure that your internal compliance and documentation needs are met. We complete onsite testing and validations. We maintain our own rigorous high standards for quality.
• Quality control
We have two Midwest locations with more than 75,000 sq. ft. of medical contract manufacturing space. Our convenient location makes us easily accessible from both coasts.