SOTA in Context of New Medical Device Regulations
The term State of the Art (SOTA) has taken on renewed significance...
Regulatory Medical Writing vs. Scientific Writing: What’s the Difference?
The healthcare and pharmaceutical industries rely heavily on preci...
EU MDR – Medical Device Labeling Changes & Challenges
Global rollout of EU MDR and other UDI-type of regulations are dri...
Clinical data for MDR/IVDR make it easy with real world
We all know that EU MDR and IVDR are clinical data hungry. When th...
TGA’s Reclassification of Medical devices around the corner. Ready?
The New Reclassification system for medical devices is round the c...
PMS & Risk Management in EU MDR
With May 2021 deadline approaching, central focus for all companie...
