Contract Medical Device Design, Development, & Manufacturing
Full-lifecycle medical device CDMO solutions, from design and development through commercial manufacturing.
ISO 13485 Certified
FDA-Compliant Manufacturing
Full Lifecycle Support
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— about meddux
Meddux Is a Medical Device CDMO
Delivering Expertise in Catheter Systems and Minimally Invasive Technologies
Our modular approach spans user-centered design and development, through custom process development and commercial manufacturing. Clients can engage Meddux for individual project phases or full end-to-end support, from concept through commercialization.
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— Why Meddux?
Why Medical Device OEMs Choose Meddux
Medical device companies face increasing pressure to shorten development timelines while satisfying regulatory requirements and preparing products for scalable manufacturing. As a specialized medical device CDMO, we help clients move efficiently from initial concept through full-scale production.
Human factors engineering integrated from project initiation
Design controls aligned with regulatory requirements
Manufacturing readiness planned during development
Catheter and minimally invasive device specialization
Flexible engagement from concept through commercialization
In-house manufacturing capabilities
— Capabilities
Manufacturing Technologies
Steerable Devices
Meddux engineers steerable catheter systems with precise deflection control, torque response, and navigation performance for complex anatomy. Development spans shaft construction, pull wire integration, and handle mechanism design through verification and validation.
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Braiding & Coiling
Braided and coiled catheter shafts are engineered to balance torque transmission, flexibility, and kink resistance for demanding clinical applications. Wire selection, pattern engineering, and reinforcement strategy are refined together from early prototyping through production scale-up.
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Laser-Cut Hypotubes
From pattern selection to final assembly, Meddux provides engineering guidance for integrating laser-cut hypotubes into finished catheter-based devices. Hypotubes are sourced and integrated from trusted suppliers and partners to meet each device's performance requirements.
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Electrode & Sensor Integration
Diagnostic mapping, energy delivery, and real-time feedback all depend on precise electrode and sensor integration within catheter-based devices. Wire routing, insulation, and connection design are engineered together through verification and validation.
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— Why Meddux?
Our Approach
Meddux uses a modular process that lets clients engage at any phase, from initial concept through regulatory approval. As products mature, we build scalable manufacturing processes alongside the device, supporting a smooth transition from design into contract manufacturing, whether you need targeted support or full end-to-end execution.
User-Centered
Design
Human factors and usability engineering ensure devices are designed around real clinical workflows, user needs, and expectations.
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Product
Development
Engineering activities progress from feasibility through verification, validation, and manufacturing readiness.
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Custom Process Development
Custom manufacturing processes are developed and validated alongside the device to support a smooth transition into scalable production.
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Contract
Manufacturing
Integrated cleanroom manufacturing and production planning support efficient transition into commercial manufacturing.
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— certifications
Quality & Certifications
Integrated Quality Systems
Meddux operates under ISO 13485 quality management systems with FDA-compliant manufacturing processes and Class 7 cleanroom capabilities. Quality activities are integrated throughout development, including design controls, risk management, design verification, validation planning, and process validation.
Regulatory Alignment
For medical device companies moving from prototype to regulatory approval, our integrated approach aligns product development, manufacturing readiness, and regulatory requirements.
Development-to-Manufacturing Integration
Many medical device development firms separate development from manufacturing. Meddux integrates engineering, quality, process development, and production planning within a single framework, whether you're a startup seeking outsourced medical device development or an established OEM looking for a long-term medical device contract manufacturer.
— testimonials
What Our Clients Say
— resources
Featured Content
— Connect
Your Medical Guide From Concept to Commercialization
Whether you need targeted engineering support, manufacturing process development, or a full development and manufacturing partnership, Meddux provides a modular approach tailored to your program requirements.
Connect with our team to discuss how we can support your next medical device program, from user-centered design through commercial manufacturing.
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