• MED Institute, Inc.

    Welcome

    We’re not new to medical device testing.

    MED Institute has tested medical devices within 42 medical specialties over the last 30 years.

  • MED Institute, Inc.

    Welcome

    Stay informed.

    We regularly present to and consult with the FDA and other global regulatory bodies. If you have questions about the latest regulations on medical device testing, we can help.

  • MED Institute, Inc.

    Welcome

    Develop a test matrix that is unique to your product.

    MED Institute partners with you to develop a test matrix that specifically meets your goals and your timeline.

  • MED Institute, Inc.

    Welcome

    Work with a partner who understands.

    MED Institute knows your industry, your needs, and your challenges. After all, we’re a medical device company too.

The MED Institute story

An engineer and an entrepreneur, after working on a pacemaker for a year in a lab, needed a way to bridge the gap between academic research and manufacturing a real world product. The answer they came up with was MED Institute.

MED helped science and manufacturing talk to each other right from the beginning. Our goal was to get ideas out of the lab and into the market where they could do some good. Our growth has been organic and based on the regulatory and clinical needs that Cook Medical encountered when developing new products. As we grew, we also learned how to work with regulatory agencies and how to help them understand the science behind our products.

Our main focus has always been getting Cook Medical products through testing and regulatory evaluations. Over the years, other companies have asked us for help. If their idea would help patients, we said yes. MED’s goal has always been to get good products to patients, and we have the knowledge and experience to help you make that happen.

Benefit from our medical device testing and regulatory experience.

You’ve been working for months, or even years, to develop your product concept. Now you need to perform the right nonclinical tests and write submissions to receive regulatory approval and reach the market.

As part of a global medical device company, MED Institute knows what it takes to guide a product through the regulatory process. We’ve been doing it for more than 30 years. So, whether you need help selecting the right regulatory approval strategy, help creating a test matrix that can demonstrate the safety of your device, or you need additional assistance preparing for and writing regulatory submissions, MED can help.