MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies
The Medical Device Coordination Group (MDCG) is a ...
Artificial Intelligence and Machine Learning for Medical Devices
In the healthcare industry, artificial intelligenc...
Medical Devices – USA/Europe Regulatory Updates Roundup, July 2024
USA
Medical Device User Fee Rates for Fiscal Year ...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has r...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing...
