OUR PROCESS

At Unity Tool (DBA Unity Precision Manufacturing), quality is the top concern—and with great quality comes great customer relationships. Every step of the way, our staff and internal processes ensure that your order will be done to your specifications. We build success together, to deliver positive outcomes, every time.

Unity works under our ISO 9001 and 13485 certifications. We operate on specialized equipment with validated processes, utilizing IQ, OQ and PQ to ensure consistent, quality-driven work.

Here’s How:

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1. Process Analysis, Design for Manufacturing (DFM), Estimate, Contract Review, Acknowledgement, and Production 

Our team of engineers reviews your specs, evaluates the machining needs for your project, makes suggestions for DFM, and provides an estimate for your order. 

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2. QUALITY MATERIALS

Unity Tool sources only the highest-quality materials from trusted suppliers to be used in our medical instrumentation. During the process analysis phase, our team will determine where to procure the materials needed for your project.

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3. QUALITY CERTIFICATION & DOCUMENTATION

Our team adheres to strict quality standards, performing to the rigorous needs of the medical device manufacturing industry. By maintaining a quality management system that complies with regulatory guidelines, we can assist in areas such as PFMEA documentation and risk analysis.

We offer complete traceability of materials within the device history records. We are ISO 9001 & ISO 13485 certified, FDA registered, and GMP compliant. Our staff uses specialized equipment with validated processes (IQ, OQ, and PQ) to consistently produce quality-driven work. 

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4. PRODUCTION

We manage all features of production in-house. Unity Tool’s shop houses a wide variety of equipment including CNC Turning, Swiss CNC, CNC Milling (including 5-Axis), Wire EDM, CAD-CAM, Inspection, and Finishing Equipment. View our complete Equipment List.        

Unity Tool has advanced robotic machining capabilities to handle challenging designs and parts with tight tolerances. Our robots are used for everything from loading parts and pallets in our mills to our new system that feeds EDMs both vertically and horizontally. They allow us to run repetitive tasks, minimizing the manpower needed while producing parts around the clock. The robots sample parts and take measurements as a part of the machining process. We even created this custom solution for a client.

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5. INSPECTION

Parts are inspected during each stage of production, including First Article Inspection (FAI) as required. Our focus is on zero defects and complete success with every part and project.

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6. SHIPPING

We know on-time deliveries are essential, and we consistently deliver medical implants and instruments worldwide on schedule. 

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