Implementing big changes in device manufacturing can be intimidating. Identifying and addressing problems can feel overwhelming, with the fear of failure looming. However, starting the improvement...
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Outwardly, the device looks like a conventional office soundproof telephone booth. In reality, it’s an autonomous health self-measurement station, empowering users to independently assess their...
Europe's healthcare field faces a critical challenge where innovative solutions are often marketed outside the continent to circumvent stringent regulations. Moreover, the sector's fragmentation and...
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...
There is an endless potential in utilizing low temperatures to achieve impressive technological feats, such as superconductivity, preserving biological material, and space exploration. Why is it not...
A poorly managed medical device NPI (New Product Introduction) is an expensive one, so being prepared is a good start. Are you looking to improve your existing device with a new manufacturing...
Do you think of quality management as only one part of the progress of bringing your software device to the market? Preferably one that can be checked out as a last step before your software device...
To succeed in taking a medical device product from idea to the market, both the design and development flow, as well as the regulatory flow, need to be considered. As the inventor or manufacturer of...