Syncrophi Systems has now achieved certification to the EN ISO13485: 2016 Quality Management System standard. This enables the company to meet the mandatory requirements of the EU’s Medical Device Regulation (Regulation 2017/745) which comes into force in May 2020. The MDR is a significant advance on the Medical Device Directive in terms of its level of detail and in particular it has been seen to raise the bar for so-called ‘Software as a Medical Device’.