16 months, a great teamwork and heavy investment in R&D have resulted in the MDR certification of our LaMagneto PEMF-therapy device.
In fact, LaMagneto is the first PEMF-therapy device in Europe to be certified according to the new EU Medical Device Regulation 2017/745 (MDR).
Not only LaMagneto, but also LaMagneto Pro and LaMagneto X models have been certified.
Together they represent the PEMF-therapy model with the widest range of preset programs based on clinical studies: effectiveness is guaranteed in the treatment of numerous osteoarticular pathologies.
But what is MDR?
It is the new EU regulation (2017/745) that has been revolutionising the European medical device system for a few years now.
MDR, in fact, sets high standards that medical device manufacturers must comply with. On the contrary, their products won’t be placed on the market.
These standards, although strict, are a real guarantee for doctors and patients, as well as a solid basis for the healthcare of the future: digital medicine.
To have been the first to reach this milestone is a huge satisfaction for us. It repays all the hard work our team has put in over the last few months. A team that has worked to ensure safety, reliability and performance over time.
Would you like more details on MDR? Click here.