Literature Search: A Medical Writer perspective
A thorough and organized search of the previously published data i...
General Safety and Performance Requirements (GSPR)
What is GSPR?        The GSPR is known as General Safety and Perf...
PMS Proactive & Reactive Data Sources for Devices
PMS processes are generating data, either continually or intermitt...
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...
