Contract Manufacturing Services for Highly Regulated Industries
Highly regulated industries and the government contract us to manufacture their parts and products because of our proven track record for product development and quality engineering. We’ve earned the privilege to be included on several OEM and government Approved Supplier Lists.
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.
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.
We are ISO 13485:2012 and ISO 9001:2008 certified, ITAR and FDA registered. We assist in preparing and compiling data for an FDA submission.
We mitigate risks in highly regulated industries by applying manufacturing best practice, quality management systems and high standards for validation and testing.
Along with your quality controls, we apply a tiered quality system appropriately designed for your program needs. We support standard qualification up to full FDA validation.
• 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.