Post-Market Clinical Follow-up Studies for Medical Devices
PMCF studies are not intended to replace the premarket data necess...
EU IVDR Performance Evaluation in 8 Steps
The new revised EU Regulation 2017/746 is focusing specific guidel...
Singapore HSA Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach
In March 2024, The document “Regulatory Guidance for Software Medi...
