Will your medical device be in direct or indirect contact with the patient? Biocompatibility will be incredibly important for the development of your device. But why is biocompatibility seemingly a...
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As of right now, the changes brought on by MDR have quickly heightened the need for clinical evaluation in the medical technology field. During the directive, the approach to clinical evaluation was...
Walking on the streets of almost any city, we can see that there are quite a bunch of building sites, cranes, and upcoming wonderful colors on the walls of new hospitals enabling more modern...
Manufacturers who have devices CE Marked to the directives MDD, AIMDD or IVDD (i.e., legacy devices) have deadlines for regulatory compliance if they want to keep their devices on the European...
The new MDR regulation has expanded the need for clinical evaluation in companies designing medical devices. The interview for my master's thesis highlighted the requirements set by the new...
