Contract Manufacturing for Healthcare OEMs
At Keller Technology Corporation (KTC), we specialize in manufacturing high-level assemblies, subsystems and fully integrated healthcare equipment, including complex electromechanical assemblies for medical equipment, ensuring compliance with cGMP standards. With extensive experience in highly regulated healthcare applications, we manufacture your product to exact specifications, providing complete documentation, traceability, and rigorous testing.
Why Choose Keller Technology Corporation for Healthcare OEM Contract Manufacturing?
Healthcare OEMs choose Keller not only for our technical expertise, but also for our technical expertise, proven reliability, and ability to function as an extension of their R&D and NPI teams. Our compliance-first approach reduces risk, accelerates time to market and ensures inspection-ready results.
- ISO-Certified Facilities:
KTC’s manufacturing facilities are ISO 9001 registered, and our Charlotte, NC, location is also ISO 13485 certified, specializing in medical device manufacturing systems and healthcare equipment applications.
- Expertise in High-Level Systems and Robotics:
Our deep knowledge of high-level system manufacturing enables us to produce complex robotic systems for healthcare OEMs, meeting the stringent demands of the healthcare industry.
- Strict SOPs and cGMP Compliance:
Decades of cGMP-compliant manufacturing experience ensure we adhere to strict standard operating procedures (SOPs), guaranteeing consistent quality and regulatory compliance.
- FDA-Ready Documentation and Validation Processes:
Our FDA-ready approach ensures every assembly meets regulatory expectations for medical equipment manufacturing, giving OEMs confidence that their systems are built to withstand audit and inspection requirements
Applications We Support in Medical Equipment Manufacturing
The team at KTC is skilled in the development and production of complex, technically sophisticated electromechanical equipment. We help healthcare OEMs bring advanced systems to market, including:
- Diagnostic instruments and imaging equipment
- Radiology and oncology systems
- Robotic surgical platforms
- Surgical machinery
- Particle accelerator and cyclotron-based medical equipment
- Medical robotics and automation systems
Our ISO 13485 Contract Manufacturing Capabilities
KTC offers flexible production support, from pilot builds to full-scale programs. Our teams specialize in electromechanical assembly for medical equipment, delivering functionally tested sub-assemblies and turnkey systems that meet the strictest quality standards.
Partner With Us
KTC’s engineering expertise and technical depth make us a trusted partner for OEMs requiring precision in the manufacturing of robotic systems and other complex medical. From initial concept through final production, our team provides full project support with a commitment to quality, reliability and compliance.
Contact us today to discuss how KTC’s custom manufacturing capabilities can support your next healthcare equipment project.
Project Profiles: Medical Equipment in Action
Explore examples of our medical equipment contract manufacturing projects.
Contract manufacturing medical system
Pharmaceutical OEM assembly manufacturing
Contract manufacturing medical system
Surgical Suite Equipment
