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...
EU MDR Implementation Extension – helps in Compliance Planning
As the extended transition deadline 26 May 2021 is approaching, we...
PMS Planning and Challenges under EU MDR
While Post Market Surveillance (PMS) is mentioned in Annex X of th...
Post-Market Surveillance Planning and Challenges under EU MDR
PMS is a collection of processes and activities used to monitor th...
