Med Device PMCF: How to get right Sample Size
Post Marketing Clinical Follow up (PMCF) study is a continuous pro...
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...
Medical Devices – Asia Regulatory Updates round up – Aug 2021
Philippines (FDA) | India (CDSCO) | Pakistan (DRA) | Bahrain (DRA)...
Medical Devices – USA/Europe Regulatory Updates round up – Aug 2021
EUROPE | US FDA
EUROPE 1. Clarification on “first certification fo...
