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, June 2024
USA
Guidance on Laboratory Developed Tests: Small Entity Complianc...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermitt...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guidel...
Post-Market Surveillance Requirements for Medical Devices
Post-Market Surveillance requirements for Medical devices as per E...
