Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2024
USA
Voluntary Malfunction Summary Reporting (VMSR) Program for Man...
Medical Devices – USA/Europe Regulatory Updates Roundup, July 2024
USA
Medical Device User Fee Rates for Fiscal Year 2025
The Food an...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data f...
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...
eIFU for IVD: Country specific regulations and Benefits
There are several benefits of using electronic Instructions for Us...
