General Safety and Performance Requirements (GSPR)
What is GSPR? The GSPR is known as General Safety and Per...
Med Device PMCF: How to get right Sample Size
Post Marketing Clinical Follow up (PMCF) study is a continuous pr...
EU MDR – Medical Device Labeling Changes & Challenges
Global rollout of EU MDR and other UDI-type of regulations are dr...
Clinical Data for MDR/IVDR Make it Easy with Real World
We all know that EU MDR and IVDR are clinical data hungry. When t...
TGA’s Reclassification of Medical devices around the corner. Ready?
The New Reclassification system for medical devices is round the ...
PMS & Risk Management in EU MDR
With May 2021 deadline approaching, central focus for all compani...