Innovative Medical Solutions
Yomura - Your Trusted Partner for Reliable, Compliant, and Cost-Effective Medical Device Production
CONTACT USEnd-to-End Contract Manufacturing
Lean & Automated
Our contract manufacturing services leverage lean principles, automation, and an experienced workforce to deliver consistent, high-quality products with reliable supply. We optimize every stage of the production lifecycle to maximize efficiency and minimize waste.
Cleanroom Environments
All manufacturing is performed in our ISO Class 8 cleanrooms, adhering to FDA and GMP regulations. Our controlled environments ensure the sterility and safety of your medical devices throughout the production process.
Qualified Processes
From initial builds to ongoing commercial manufacturing, our contract manufacturing services are backed by rigorous quality management systems, process validations (IQ/OQ/PQ), and batch traceability. You can trust Yomura to deliver compliant, high-performing products.
Turnkey CDMO Solutions
Concept to Prototype
Our team of experienced engineers, tool designers, and manufacturing specialists will guide your product from the initial concept through the design, prototyping, and tooling stages.
Process Validation
We apply scientific molding principles and conduct rigorous IQ/OQ/PQ qualifications to ensure your manufacturing processes are validated and consistent.
Pilot to Production
With our CDMO services, we'll support you through pilot runs and full-scale production ramp-up, ensuring a seamless transition to commercial manufacturing.
Highly Specialized Capabilities
In-House Precision Tooling
Our state-of-the-art tool room with high-speed CNC mills and EDM equipment allows us to produce high-cavity, tight-tolerance molds and components in-house, ensuring quality and control.
Automation & Industry 4.0
Our manufacturing cells integrate robotics, machine monitoring, automated measurements, and data analytics for continuous process control and optimization.
Scientific Molding Expertise
We apply scientific molding principles and rigorous validation to achieve consistent, high-performing injection molding processes for your medical devices.
Cleanroom Assembly & Testing
Our skilled staff operates in an ISO Class 7 cleanroom environment, ensuring the highest levels of cleanliness and precision for complex assembly and functional testing.
Comprehensive Quality Management
ISO 13485 & ISO 9001
Yomura's quality management system is certified to the ISO 13485 and ISO 9001 standards, ensuring robust processes for change control, CAPA, and batch traceability.
ISO 13485 & ISO 9001
Our cleanroom packaging capabilities adhere to ISO 7 standards, utilizing EO sterilization processes and FSC-certified materials to protect the integrity of your medical devices.
Regulatory Compliance
All of our manufacturing operations are performed in compliance with FDA and GMP regulations, ensuring your products meet the highest standards for safety and efficacy.
Continuous Improvement
We are committed to a culture of continuous improvement, constantly evaluating our processes and implementing lean principles to drive quality, efficiency, and cost-effectiveness.
Diverse Product Portfolio
SVIC Hypodermic Safety Needles
Our highly-engineered safety needles provide enhanced protection against needlestick injuries while maintaining precision and performance.
Travelscoot Folding Mobility Scooter
A compact, lightweight, and durable mobility scooter designed to offer maximum portability and independence for users.
Click Cross Micro- Precision Flow Control
Advanced flow control valves with micron-level precision, enabling accurate fluid management in critical medical applications.
Contraceptive Coils
Innovative contraceptive solutions that provide long-lasting, reliable birth control with controlled hormone release.
Proven Track Record
Breakthrough Innovations
Yomura has a history of partnering with companies to bring groundbreaking medical devices and technologies to market, from novel delivery systems to cutting-edge implantables.
High-Precision Components
Our expertise in scientific molding, automation, and cleanroom manufacturing enables us to produce highly specialized, tight-tolerance components for the most demanding medical applications.
Reliable Supply Chain
With our vertically-integrated capabilities and lean manufacturing practices, we ensure a reliable, cost-effective supply of your products to support your global distribution needs.
Ready to Elevate Your Medical Device Production?
Discover How Yomura Can Optimize Your Medical Device Manufacturing
Whether you're a medical device startup or an established manufacturer, Yomura has the capabilities, experience, and commitment to quality to become your trusted production partner. Our end-to-end services, from design to delivery, are tailored to help you overcome your unique challenges and bring your innovative products to market efficiently and compliantly. Let's discuss how we can elevate your medical device manufacturing to new heights.
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