GMED designated in accordance with the MDR

The French notified body GMED (number 0459) has just been designated in accordance with the MDR ! It is the 15th notified body to successfully pass the designation milestone. Its designation perimeter is among the most expanded. It is available on the NANDO database...

How the MDR will impact your regulatory watch

Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch? The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to...