Meddux: A CDMO Specializing in Interventional and Therapeutic Medical Devices
Meddux Is Your Guide to Medical Device Engineering
Meddux is a medical device CDMO specializing in complex catheter-based and minimally invasive therapeutic devices. Our teams integrate Engineering, Quality, and Manufacturing within a single framework, supporting programs from early concept through scalable production.
Working across multiple clinical applications, Meddux applies engineering expertise to solve complex design and manufacturing challenges. By focusing on manufacturability, process capability, and long-term product performance from the outset, the team helps our clients move confidently from technical feasibility to commercial production.
Our experience as a medical device CDMO specializing in complex catheter-based and minimally invasive devices enables seamless collaboration between Engineering, Quality, and Production teams throughout the product lifecycle.
Vision
Our vision is to improve patients' lives by accelerating the development and commercialization of innovative new medical device technologies and therapies.
Mission
Our mission is to be a long-term partner for the design, development, and manufacture of complex medical devices. We are an engine for our customers' success from concept through commercialization.
— process
Explore Our Approach
Our integrated methodology connects Engineering, Manufacturing, and Quality within a single framework. Clients can engage Meddux at any stage while maintaining continuity throughout engineering, process development, and production.
User-Centered
Design
Human factors and usability engineering ensure devices are designed around real clinical workflows, user needs, and expectations.
Learn More
Product
Development
Engineering activities progress from feasibility through design controls to verification and validation and manufacturing readiness.
Learn More
Custom Process Development
Custom manufacturing processes are developed and validated alongside the device to support a smooth transition into scalable production.
Learn More
Contract
Manufacturing
Integrated cleanroom manufacturing and production planning support efficient transition into commercial manufacturing.
Learn More
— Why Meddux?
What Sets Us Apart
Meddux supports the full concept-to-commercialization pathway, combining engineering depth, structured Quality Management Systems, and manufacturing readiness to move programs forward with speed and confidence.
Speed to Market
Engineering, Manufacturing, and Quality planning begin in parallel to reduce unnecessary design iterations and transfer delays. Early consideration of design for manufacturability helps accelerate progression from feasibility through validated production.
CGMP / FDA Registered Production Processes
Documented Quality activities are integrated throughout engineering and manufacturing rather than introduced at the end of development. This structured approach supports regulatory expectations and efficient product transfer into manufacturing.
Full Lifecycle Partnership
Engineering, process development, validation, and manufacturing teams collaborate within one integrated framework. This continuity simplifies communication, reduces handoffs, and supports consistent program execution.
Device Expertise
Meddux brings expertise in catheter systems, minimally invasive technologies, and sterile disposable device capabilities across multiple clinical applications. Deep engineering knowledge supports practical solutions for complex device programs.
.webp)
— certifications
Quality & Certifications
Integrated Quality Management Systems
Meddux operates under an ISO 13485:2016 certified Quality Management System with FDA registered 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.
— upcoming
Events
October
31
2026
TCT
San Diego, California
Meddux is attending TCT 2026 in San Diego, a leading global meeting for interventional cardiovascular medicine. We’ll be there to connect with clinicians, innovators, and device teams advancing coronary, structural heart, and endovascular technologies and discuss how Meddux can help bring complex interventional devices from concept through production.
November
3
2026
Innovation Summit San Diego
San Diego, California
Meddux is attending the Innovation Summit in San Diego, bringing together leaders in interventional cardiovascular innovation across coronary, structural heart, and endovascular therapies. Our team will be there to connect with clinicians and device companies working to advance new interventional technologies from development toward manufacturing.
November
18
2026
MEDevice Silicon Valley
Santa Clara, California
Meddux is attending MEDevice Silicon Valley in California, where medical device innovators come together to explore the latest technologies, solutions, and approaches shaping product development and manufacturing. We’ll be there to connect with medical device teams and discuss how Meddux supports programs from early development through manufacturing.
— 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.
.svg)
Capabilities
Markets
Our Approach
About Us
Resources
© 2026 All rights reserved
made by
.png)