mbits has long been prepared...
May 26, 2020 marks the start of the scope of the new Medical Device Regulation (MDR) EU 2017/745. The new regulation on medical devices poses major challenges for many medical technology companies.
mbits employees have been introduced to agile software development and the company's comprehensive quality management system from the very beginning. Knowledge is always kept up to date via regular training and seminars.
These measures have led to mbits already receiving the certification recommendation by TÜV Süd at the beginning of December 2019 in accordance with the requirements of the new MDR 2017/745 within the scope of our "Diagnostic image viewer with image processing functions". Good luck and stay up to date!