In the field of creating medical devices, there's a crucial meeting point between usability and innovation. The ideas and needs of both creators and users come together to impact the direction of...
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We all know that our world continues to become more digitalized. But did you also know that this is happening alongside a shift in our healthcare? Patients who used to be more passive in receiving...
In the ever-evolving landscape of medical device development, usability and innovation intersect significantly. The perspectives of developers and end-users converge to shape the future of medical...
Sometimes an everyday wellness device might become not just a companion in your journey to better health, but a powerful medical tool that empowers you to monitor, manage, and even predict your...
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...
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...
