Among some of the first in the field of AI in radiology, Radiobotics has just been certified according to ISO 13485 and according to the new European Medical Device Regulations (MDR). Also, our product RBknee has been CE marked under the MDR certification as a class IIa medical device. This is something we’ve worked on for some time and it is something we are very proud of.
Medical Device Regulation (MDR) is the regulatory framework in the European Union. Our certification concerns the production and distribution of all medical devices and software that provides decision support. This ensures patient safety, and the standards help medical device companies develop recipes for how they can build their products in an as safe and effective manner as possible. The certification means a lot to us because now we can demonstrate the quality and safety of our technology as it is indeed meeting the high European standards. More importantly, the certification also means that we can continue to support the European hospitals and clinics with our existing and future products in compliance with the new regulation. At Radiobotics, safety, quality and transparency have always been crucial to us and passing the thorough MDR audit is a great achievement that we at Radiobotics are very proud of.