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...
EU MDR Implementation Extension – helps in Compliance Planning
As the extended transition deadline 26 May 2021 is approaching, w...
Use of Retrospective RWD for EU MDR Compliance
As EU MDR has already entered into force and will be applicable i...