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The FDA has released a new Emergency Use Authorization (EUA) template to help devicemakers develop COVID-19 tests for at-home self-collection. Read More
The European Commission’s Medical Device Coordination Group (MDCG) outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the new Medical Device Regulation. Read More
TEAM-NB, the European Association of Notified Bodies for medical devices, reported that CE certificates spiked by nearly 50 percent last year. Read More
The FDA’s changes in response to the COVID-19 outbreak will lead to permanent improvements at the agency, predicts FDA Commissioner Stephen Hahn. Read More
Sponsors musts report any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, the group said. Read More
TEAM-NB, the European Association of Notified Bodies for medical devices, reported that CE certificates spiked by nearly 50 percent last year. Read More
The European Commission’s Medical Device Coordination Group (MDCG) outlined in a new guidance how devicemakers should report safety incidents for clinical studies under the new Medical Device Regulation. Read More