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