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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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Considerations for designing and building an electronic data capture system for clinical trials (part 1)
August 7, 2019Part 1: Considerations for designing an electronic data capture system with users in mind Electronic data capture...
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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...
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Regulatory research on IDE exemptions: A case study in persistence (part 1)
June 27, 2019A client presented us with a simple question – Do we need to submit an Investigational Device...
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Science of Patient Input (SPI) Part 3
June 17, 2019Patient input into study design – participation considerations. The last, in a series about the science of...
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Science of Patient Input (SPI): Part two
May 29, 2019Patient input into study design – endpoints of value and thresholds of “significance”. The second of three,...
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Science of Patient Input (SPI): Part one
April 22, 2019The first of three, in a series about the science of patient input. It is tempting to...
