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.

DESIGN FOR
MANUFACTURING

Pilot manufacturing experts.

PILOT
Manufacturing

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!)

YOUR MANUFACTURING PARTNER

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.

Is MIS the right partner for you?

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.

Set up a meeting with our manufacturing experts

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.

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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.

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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

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