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 ...
Effect of GDPR on Medical Devices in EU
Growth of technology brought forth internet enabled Medical Device...
