MEDICAL CONTRACT MANUFACTURING
Unity Tool is a 3rd generation Minnesota based medical contract manufacturing company of precision machined parts and assemblies. We are one of a select few precision manufacturers experienced in medical instruments for medical specialties and orthopedic implants. Medical specialists rely on instruments and implants that can perform to their exacting standards.
Unity Tool meets the needs of medical OEM’s by meeting regulatory guidelines and employing stringent quality standards. Our goal is to make consistent, highly reliable medical instruments and implants, which give the best outcomes when used by medical providers with their patients.
WHAT SETS US APART FROM OUR COMPETITORS
“We are all about personalized service. We adapt to our customers’ needs and circumstances and work with our customers to manufacture products and deliver excellence”
- Unity Tool is a complete, full-service manufacturing company. We manage all the features of production in-house, as well as the quality and certification processes. Every step of the way, we examine the system and use a continuous improvement process for process development, procurement, materials management, manufacturing, final assembly, finishing and delivery.
- We believe state-of-the-art equipment is essential for quick delivery of precision-machined products. Unity Tool houses over a hundred pieces of equipment in our shop and we have a unique blend of automation and detailed processes. Automation and robotics allow machining 24/7.
- Unity Tool is a precision-driven global contract manufacturing company. The work we do is a source of pride. Our commitment to absolute quality, quick turnaround times, and commitment to complete satisfaction make us a preferred manufacturer of medical-grade products. We focus on preventing errors and increasing efficiency while decreasing the risk of regulatory actions.
- Transparency and experience are why our customers trust us. Unity Tool has been a manufacturer servicing the medical industry for over 50 years. We offer complete traceability of materials and processes thru the device history record. We are ISO 9001 & ISO 13485 certified, FDA registered, and GMP compliant.
- Partnerships are the lifeblood of our business. By working together with our supply partners and our customers, we can navigate challenges, satisfy prospects, and create the best possible implant or instrument.
- Our experience in scheduling and managing delivery arrangements gives peace of mind to our customers. We know on-time deliveries are essential in delivering medical implants and instruments worldwide.
SERVICES WE PROVIDE
We provide the following manufacturing processes:
- Multi-axis Swiss, up to 5-axis Milling and live tool Turning
- Wire EDM
- Hole Popping
- 3D Printing
Medical Implant Manufacturing
As a leading medical orthopedic implant producer, we have extensive experience manufacturing medical implants such as bone screws. The range and development of our resources are a vital part of medical tool manufacturing.
Medical implant devices require a clean, capable manufacturing facility that can deliver impeccable quality consistently. We employ validated processes along with our proven ability in precision manufacturing from a highly trained, experienced staff.
Medical Contract Manufacturing
We are one of the leading U.S. owned medical contract manufacturers. We support contract equipment manufacturers by:
- Assisting in overcoming part or assembly difficulties through engineering.
- Providing full shop service from manufacture to final assembly and packaging.
- Improving product manufacture that lowers unit costs.
- Providing premier finishing.
- Ensuring quality assurance and regulatory compliance.
OUR PLEDGE TO OUR CUSTOMERS
We believe our customers deserve to receive product that meets their specifications and is delivered to them in a timely fashion. We do this by being committed to maintaining an effective Quality Management System, through manufacturing excellence, continual quality improvement and honorable customer relations.
Unity Tool provides the highest quality of precision manufacturing with innovation and customer care at the core of our values. We pride ourselves on our collaborative confidential partnerships with our customers, investment in continuous improvement methods, hard work, quality service, availability and flexibility to get the job done right. No job is too large or too small!
Let us help you with your medical part or assembly project.
FULL DOCUMENTATION & TRACEABILITY
We provide full documentation/Device History Records, including Inspection Reports, Traceability Documents, and Certificates of Conformance.
CERTIFICATIONS & COMPLIANCE
Our quality system is driven by the following:
GMP Compliant CFR820
FDA Registered: 9025123