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Quality Management

Our quality mindset is integral to everything we do. We are a lean manufacturer with green belts on staff, and we provide updated training. Continuous improvement informs all aspects of production and inspection equipment, software systems, and personnel instruction.

Quality begins well before production. Our process begins with a supplier qualification program to ensure quality of incoming material. Our process continues with evaluating designs for robust manufacturability, testing and service, and creating necessary documentation. We focus on quality as if life depends on it, because often it does. Many of the products we build save lives every day. We maintain compliance to registrations and certifications.

Production QMS

Once in production, our quality management system (QMS) monitors and measures our manufacturing activity and verifies that product requirements are consistently met. Our SPC team monitors inspection and test results from each key process area and identifies areas requiring improvement.

Information Management

We continually invest in our infrastructure to maintain build consistency throughout the production and reporting process. Our IT infrastructure team developed an integrated platform that allows real time information to and from the line. Work instruction delivery is coordinated with product movement through production so that information arrives at the time it is needed. And data can be pulled into a report tailored to the needs of each customer.

We coordinate any required or recommended improvements from part sourcing through final assembly and test through our change management system to ensure effective and accurate documentation and record control.

Training

Our commitment to the training and mentoring of our people results in improved quality output for our customers. If a customer needs us to know a skill or procedure specific to their product, we will build a course around it for the appropriate personnel. The Learning Center is the epicenter for both training and cultural assurance.

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Core Certifications

ISO 9001, ISO 13485, ITAR Registered, FDA Registered, Woman-Owned Small Business certified (WBE, WOSB)

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What Our Customers Say

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