TGA’s Reclassification of Medical devices around the corner. Ready?
The New Reclassification system for medical device...
PMS & Risk Management in EU MDR
With May 2021 deadline approaching, central focus ...
EU MDR Implementation Extension – helps in Compliance Planning
As the extended transition deadline 26 May 2021 is...
ISO 14971:2019 – Updates & older Version Differences
The third edition of ISO 14971 was finally release...
EUDAMED and EU Medical Device Nomenclature
The European Commission explain the details of how...
Med Device PMCF: How to get right Sample size
Post Marketing Clinical Follow (PMCF) is a continu...
