The new EU Medical Device Regulation (MDR) and the In vitro Device Regulation (IVDR) are expected to have a far-reaching impact for device manufacturers doing business in Europe.
Topics: EU Regulatory System
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
The new EU Medical Device Regulation (MDR) and the In vitro Device Regulation (IVDR) are expected to have a far-reaching impact for device manufacturers doing business in Europe.
Topics: EU Regulatory System
It’s the age old debate… Is the US regulatory system or the EU regulatory system better for the medical device industry? Recently in PLoS Medicine Journal the results of a systematic review was published that evaluated the two systems.
Topics: Medical Devices, Gold Medal, US Regulatory System, EU Regulatory System