IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has r...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across t...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Dec 2022
USA (FDA) | EUROPE (EU) | UNITED KINGDOM (MHRA) | ...
New EU MDR/IVDR Authorized Representative guidance summary
For manufacturers who are not established in the E...
Trend reporting in IVDR context and Requirements
Manufacturers of devices, made available on the Un...
Medical Devices – USA/Europe Regulatory Updates Roundup, Apr 2022
EUROPE (EU) | USA (FDA) | ROW – BRAZIL (ANVI...
