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.
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Product
Development
Engineering activities progress from feasibility through design controls to verification and 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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— 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.
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— 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
7
2026
MPO Summit
Salt Lake City, Utah
Meddux is attending the MPO Summit in Salt Lake City, an event focused on the evolving medical device manufacturing and outsourcing landscape. We’ll be there to connect with OEMs and industry partners and discuss how integrated engineering and manufacturing capabilities can help move medical device programs toward scalable production.
October
14
2026
NASS North American Spine Society
San Antonio, Texas
Meddux is attending the NASS 2026 Annual Meeting, where professionals and industry leaders come together to explore advances in spine care, surgical technologies, and medical devices. We’ll be there to connect with teams developing innovative spine solutions and discuss how Meddux can support device development and manufacturing.
October
18
2026
AdvaMed MedTech Conference
Boston, Massachusetts
Meddux is exhibiting at The MedTech Conference, where leaders from across the medical technology industry come together to connect, exchange ideas, and explore what’s next in MedTech. Visit us at booth 1035 to meet our team and learn how our integrated development and manufacturing capabilities support medical device programs from early concepts through production.
October
28
2026
MD&M Midwest
Minneapolis, Minnesota
Meddux is attending MD&M Midwest in Minneapolis, where medical device professionals, engineers, and manufacturers come together to explore technologies and solutions across the product lifecycle. We’ll be there to connect with MedTech teams and discuss how integrated development and manufacturing expertise can help turn device concepts into scalable products.
— 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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