Since its foundation in 2004, B.Well has constantly been striving for development in order to design the highest quality medical devices. Since 2012, B.Well Swiss has been headquartered in the innovation cluster located in the Swiss canton of St. Gallen, one of the major economic zone of Switzerland and Europe in the field of precision-work. The quality management system of B.Well Swiss AG is certified to comply with the international norm ISO 13485:2016. B.Well Swiss products comply with the requirements of the Medical Device Directive (MDD) 93/42/EEC or Medical Device Regulation (MDR) (EU) 2017/745.