Design and Development

With over two decades of experience in liquid silicone manufacturing, the development of innovative products has been the primary focus of our business and is where we excel. Our industry-wide reputation is based on collective knowledge that is unsurpassed for ease of production and FDA compliance. Our team can lead your device through complete life cycle management from initial product development to final assembly, quality assurance and continuous product improvement.

We use proven methodology, tooling and processes to speed time to market and exceed both design and business objectives.

Our start-to-finish capabilities include:

Proposal

Customer needs are matched with MRI’s capabilities envisioning robust, integrated products centered around our viable expertise with liquid silicone manufacturing.

Definition

Specifying the requirements of the product in terms of regulatory objectives, intellectual property implications, and design concepts.

Design

Concept generation, prototype critical design features, developing preliminary test methods, identifying packaging and labeling requirements, tooling requirements, sterility methodology, packaging needs.

Development

Review of prototypes, concurrent process engineering, finalizing tooling needs, final proof of concept, manufacturing documentation.

Manufacture

Finalizing processes, procurement of raw materials, standardization of equipment, fixtures, tooling product launch, sampling.

Validation

Reliability performance test reports, regulatory compliance. Stewardship through approvals (including 501K approvals) using our ISO 13485:2003 certification and FDA registration.

In the medical industry there is no company as qualified as MRI Medical to develop your original medical device concept and turn it into working and marketable product success story. We do it all from concept to market launch.

If you have a unique silicone medical device to introduce and are looking for the right partner MRI Medical should be on your team.