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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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EU 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...
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Regulatory research on IDE exemptions: A case study in persistence (part 1)
A 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
Patient 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 2
Last time we discussed how patients’ opinions can shape the design of a clinical study by altering...
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Science of Patient Input (SPI): Part 1
The first of three, in a series about the science of patient input. It is tempting to...
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