CATHETER DESIGN

Catheter Design & Development Services.

At MIS, catheter design services are our specialty. We have built our company around offering a winning combination of industry veterans and in-house technologies to expedite quality product development for medical devices.

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Rapid prototyping experts.

Rapid
Prototyping

Product development experts.

Product
Development

Testing services for catheter systems.

Testing
Services

Medical device Design History File (DHF) management.

DHF
Management

Your catheter commercialization partner.

Market
Commercialization

Download the catheter development Ebook.

Download Our Design Control Process

Discover what the journey to commercialization looks like with our design control process. This is a comprehensive look into the 5 phase process MIS created for catheter development.

Get The Guide (it's free!)

A solution for every device

A-La-Carte catheter design & development.

Whether you are in need of low-volume prototypes to prove feasibility, or you are looking for a partner to take you through regulatory submission and commercialization, we meet your needs wherever you are.

A catheter handle made by Midwest Interventional Systems.

Off-The-Shelf Catheter Handle

Reach your milestones faster by leveraging our internal handles.

Get through animal studies, first-in-human trials, feasibility studies or whatever milestones you face next with our fast and cost effective internal handles. With a wide range of French support and a variety of built-in features, you can fast-track your catheter system's success.

Use our handle for your catheter system

5-Phase Design Control Process

We follow a proven 5-phase design control process to design and develop your medical device.

Concept development & Optimization.

Develop and evaluate initial designs, design inputs, project requirements, project budget and timeline, and any additional customer requirements.

Tell us about your design needs

Establishing target design requirements.

Continuing to develop the product design, the associated manufacturability processes, and the required test methods.

Tell us about your Feasibility needs

Proving safety and device functionality.

conduct design verification and validation testing to demonstrate that the design outputs meet the design inputs.

Ask about our in-house validated test methods

Phases 4 & 5, and beyond.

The final phases of the Development Process are Process Validation and Commercialization. The purpose of Process Validation is to establish a manufacturing process that consistently meets all product requirements without the need for ongoing verification testing.

Transfer Your Device Into Production

Tell Us About
Your Project.

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