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...
ISO 14971 Risk Management for Medical Devices
This standard specifies terminology, principles and a process for ...
Differences between US FDA and EU MDR Usability Studies requirements
Regulatory frameworks for usability testing
IEC 62366-1:2015 is an...
EU Med Devices: Increase in MDR applications
Last year the European commission has collected the data from the ...
