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MRI Safety of Electrically Active Devices
We have recently expanded our capabilities to include MRI safety evaluation of electrically active devices to our...
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COVID-19 Update
Dear valued clients, With the rising global concern around COVID-19, we wish to let you know that...
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European Medical Device Regulation (MDR)
The European Medical Device Regulation (MDR) is a new set of regulations that will become effective May...
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FDA Draft Guidance
Our multi-disciplinary team has extensive experience in medical device simulation and testing, including but not limited to...
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Claiming Equivalency Under EU Medical Device Regulation
Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a...
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Medical Device Classification
Understanding the classification of your medical device before CE marking is a critical step as it affects...
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Clinical Evaluation Report (CER) Literature Searching
To 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
Since 2015, MED Institute has been focused on developing its partnership with medical device and biotech companies...
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Scientific communication or ghostwriting?
In 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)
Part 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)
In 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)
In our previous blog post, we described our preliminary regulatory research study on whether our client’s electronic...
