EUDAMED and EU Medical Device Nomenclature
The European Commission explain the details of how a future system...
Use of Retrospective RWD for EU MDR Compliance
As EU MDR has already entered into force and will be applicable in...
Med Device PMCF: How to get right Sample size
Post Marketing Clinical Follow (PMCF) is a continuous process to a...
Labeling findings from FDA and other Agencies audits summary
Regulatory environment has become increasingly complex and making ...
