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