Our mission
MED Institute is dedicated to bringing new medical products to market that are safe and effective for patients. We leverage our engineering, regulatory, and clinical expertise to support companies who need help moving their product from concept to commercialization.
We can help you find your regulatory path through the development process.
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We have helped medical devices within 42 medical specialties reach markets around the world.
ABOUT MED INSTITUTE
We have over 250 accredited tests and are actively validating new methods.
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We provide thoughtful guidance and quality clinical trial services to our clients, focusing on safety and effectiveness.
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Our Services
Accelerate your product development.
Research Collaboration with the FDA
Since 2016, we have collaborated with the FDA on a research project to assess radiofrequency (RF) induced heating of passive metallic medical devices during magnetic resonance imaging (MRI). The information learned will provide engineers an understanding of thresholds for heating. It will also support the design of appropriate MRI safety testing strategies.
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Latest News
The latest news and thought leadership from MED Institute.
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Clinical Evaluation Report (CER) Literature Searching
January 7, 2020To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
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Avoid these pitfalls in early design phases
October 24, 2019Since 2015, MED Institute has been focused on developing its partnership with medical device and biotech companies...
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Scientific communication or ghostwriting?
September 10, 2019In medical science reporting, ghostwriting has a bad rep. Deservedly so, in many cases. Why is this...
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Clinical trials: considerations for designing and building an electronic data capture system (part 2)
August 29, 2019Part 2: Considerations for designing an electronic data capture system for clinical trials with sponsors/CRO in mind....
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Clinical trials: considerations for designing and building an electronic data capture (EDC) system (part 1)
August 7, 2019In clinical trials, electronic data capture (EDC) systems are widely used to collect data such as patient...
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Regulatory research on IDE exemptions: A case study in persistence (part 2)
July 24, 2019In our previous blog post, we described our preliminary regulatory research study on whether our client’s electronic...
