cosinuss°, a leading provider of cutting-edge medical technology, has just received the highly coveted CE mark after successfully navigating the Medical Device Regulation (MDR) process for its innovative c-med° alpha sensor. This achievement puts cosinuss° in an exclusive group of companies that have met the rigorous standards set by the European Union for medical devices, making their products eligible for sale throughout the EU.
Getting the CE mark for a medical device after the new MDR has become a very intensive and challenging process, requiring extensive documentation, testing, and evaluation. The MDR, which came into effect in May of 2021, raised the bar extremely high, making the CE mark an even more sought-after achievement. cosinuss° faced these challenges head-on, working tirelessly to ensure that their c-med° alpha sensor met the highest standards for safety and performance.
“We are immensely proud to be one of the first companies that received medical CE in the framework of this new regulation. It finally gives us the recognition for our hard work of the last almost two years. ”, states Johannes, CEO of cosinuss°.
The c-med° alpha is a cutting-edge in-ear vital signs sensor that provides real-time monitoring of oxygen saturation, body temperature and heart rate. Its ergonomic and award-winning design, combined with its advanced technology, make it an ideal tool for easy and continuous access to an individual’s vital parameters. The CE mark ensures that the c-med° alpha sensor has been thoroughly tested and meets the EU’s rigorous standards for medical devices.
This achievement is a testament to the company’s commitment to innovation, safety, and quality. With the c-med° alpha sensor now available for sale throughout the EU, cosinuss° is poised to revolutionize the way that individuals monitor and manage their health.