Quality
Patient safety, compliance, and product quality come first.
We are Kaier
Your one-stop CDMO and OEM for medical and surgical devices.
From a small machine shop in 1990 to a global medical device manufacturer, Kaier has grown into an FDA-registered company with factories in Taiwan, China, and the United States. With Class 100,000 cleanrooms, smart machining lines, and advanced manufacturing technologies, we deliver end-to-end solutions from design and development to prototyping, validation, and production. Our main business is contract manufacturing of medical and surgical devices — endoscopes at the core, plus high-precision devices and components for cardiovascular, orthopaedic, robotic surgery, and gynecological diagnostic applications.
Vision
To be the most trusted global CDMO partner for medical device innovation.
Mission
Enable medical device companies with high-quality, innovative solutions that bring products to market faster and more reliably through engineering and manufacturing excellence.
Core Values
Unity
Collaborate as one team, speak with one voice.
Integrity
We act with honesty, accountability, and respect.
Customer
We put our customers’ success at the heart of every decision.
Know-How
We leverage expertise, innovation, and engineering excellence to create value.
Corporate
Responsibility
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Kaier is committed to corporate responsibility, with a strong focus on environmental sustainability, social responsibility, and ethical governance. We promote sustainable practices through energy-efficient operations, the use of renewable energy, and waste reduction initiatives such as recycling and reuse, while setting clear targets for greenhouse gas emission reduction.
We strive to build sustainable, equitable, healthy, and diverse communities by integrating innovative digital transformation and information technology solutions with strong environmental, social, and governance performance. This commitment guides every aspect of our business, from how we design and develop new projects to how we operate and collaborate with stakeholders.
The company is also dedicated to supporting employee well-being through comprehensive health and wellness programs, ensuring safe working conditions, and fostering a diverse and inclusive workplace.
Our Commitment to Quality
Quality that Meets the Highest Standards
Quality is the cornerstone of our operations. Every employee at Kaier understands their role in upholding our quality standards, ensuring that we consistently deliver products that meet and exceed expectations.
We deploy the latest quality technologies and systems to ensure all our products meet design specifications.
Quality Policy
We are committed to providing high quality products and services that will exceed customer expectations, comply with regulatory requirements, and maintain an effective quality management system.
We deploy the latest quality technology and systems to ensure that all our products meet design specifications.
Regulatory And Compliance
With decades of medical device experience, we have developed a thorough understanding of the complex regulatory environment. Every product is manufactured to exact specification, in full compliance with applicable quality and regulatory guidelines.
- ISO 13485 Certified, Medical Device Single Audit Program (MDSAP) certified, and Class I, II, III, and combination devices, including Premarket Approval (PMA) Product Support
- Metrology and Microbiology Laboratories
- FDA registered and compliant with the Quality System Regulation CGMP
- ISO 7 and ISO 8 Certified Cleanroom Controlled Environments
What Sets Us Apart
Kaier drives growth through continued investment in automation at its smart office and factory, enhancing output, quality, and consistency. This manufacturing platform sets new benchmarks for productivity and innovation.
Precision Engineering
Expertise in tooling, mold design, and materials science.
Advanced Manufacturing
Utilization of cutting-edge machinery and automation for high-precision production.
Cleanroom Capabilities
Facilities designed to meet medical-grade production standards.
Collaborative Development
Partnering with clients for co-development, prototyping, and iterative testing.
End-to-End Solutions
From design for manufacturability (DFM) to final assembly and packaging.
Partner with Kaier
Let’s Build the Future—Together
At Kaier, we believe the best innovations are built through strong partnerships. We’re ready to collaborate, bringing your vision to life with precision, reliability, and speed.
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