IN-house catheter manufacturing

Scalable & Sustainable Catheter Manufacturing.

At MIS we are building the ideal environment for medical device production. Our in-house manufacturing group is designed to seamlessly transfer your device from development to production.

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Design for manufacturing experts.


Pilot manufacturing experts.


3,500 square feet of Class 7 Cleanroom space.

Class 7
Clean Room

Catheter device assembly experts.

Catheter &
Device Assembly

Download the catheter development Ebook.

Download the Manufacturing Guide

Take control of your manufacturing process by understanding the essential considerations for manufacturing your device. This guide will walk you through Design Considerations, Manufacturing Timelines, Regulatory Considerations, and much more.

Get The Guide (it's free!)


Set Your Catheter System Up For Manufacturing Success.

Finding success in medical device manufacturing starts with choosing the right partner. At MIS, we don't succeed until you succeed. Our dedicated manufacturing team has decades of experience with bringing catheter systems to sustained production.

Book your 1-on-1 today.
MIS catheter engineer manufacturing catheter systems in a class 7 cleanroom.

Suite of in-house CATHETER capabilities

From Pilot Production to Sustained Manufacturing, We Have You Covered.

3,500 Sqft. Class 7 Clean Room Space

Manufacture your device in the same building as the engineers who are designing it.

Internal Balloons & Extrusions

Save time and money by leveraging our in-house component manufacturing capabilities.


We have the equipment to handle nearly any catheter manufacturing process.

The 4-Track Manufacturing Transfer

Our four-track Manufacturing Transfer Process is designed to expedite the relocation, expansion, or strategic positioning of your manufacturing line.

Comprehensive Understanding of Your Needs.

We sit down with your team to define a clear path towards successfully executing the manufacturing transfer.

Book your 1-on-1 today.

Developing Process Equivalency.

Our engineering & manufacturing start process development while ensuring all device requirements are met. At the end of the phase, we provide a process equivalency report to demonstrate our design & processes are substantially equivalent.

Ask about transferring your device

Proving safety and device functionality.

Process validation is driven by customer certification requirements that are non-verifiable. MIS will execute process validation, or support lot release testing for product release and certification.

Ask about transferring your device

Dedicated to Production Preparedness.

We continue support of the production line with planned ramp strategies, aggressive OEE targets, and a robust VIP program to achieve short and long term cost targets.

Transfer Your Device Into Production

Tell Us About
Your Project.

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