EU MDR 2017/745 What Changed?

EU MDR 2017/745 What Changed in regard to the Medical Device Directive and how to implement them in your current quality management system?

The new medical device regulation, EU MDR 745/2017, has several additional criteria in regard to previous legislation. This new regulation also has a stronger connection to EN ISO 13485:2016. What modifications have been made to the prior medical device regulation, and how must you implement these changes in your current quality management system?

Happy World Standards Day!

Happy World Standards Day!

World Standards Day 2021 is about our shared vision for a better world. Every year on 14 October, the members of the IEC, ISO and ITU celebrate WSD.