MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies
The Medical Device Coordination Group (MDCG) is a regulatory body ...
Artificial Intelligence and Machine Learning for Medical Devices
In the healthcare industry, artificial intelligence (AI) refers to...
Medical Devices – USA/Europe Regulatory Updates Roundup, July 2024
USA
Medical Device User Fee Rates for Fiscal Year 2025
The Food an...
US FDA’s UDI Requirements
FDA UDI regulations were released in the final UDI Rule on Septemb...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publishe...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guidel...
