Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Jan 2025
USA
Guidance on Premarket Approval Application and Humanitarian De...
New/Key MDCG guidances in 2024
The European Commission continues to refine and expand regulatory ...
Medical Devices – USA/Europe/Asia Regulatory Updates Roundup, Aug 2024
USA
Voluntary Malfunction Summary Reporting (VMSR) Program for Man...
Clinical Data Usage for Medical Device Submissions in EU and US
Clinical Data for Medical Device Submissions in EU
Clinical data f...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
Technical Documentation Best Practices for EU MDR
Manufacturers shall ensure the conformity of medical devices being...
