Understanding EU MDR Clinical Evidence Required for Legacy Medical Devices as Outlined in MDCG 2020-6 Ever since the release of MEDDEV 2.7-1 rev 4 in 2016 and the publication of the European Medical Device Regulation (EU MDR) in 2017, manufacturers have been coming to grips with the realization that their existing clinical data was not [...]
Oriel STAT is a New Jersey-based consulting firm that provides MDSAP auditing, QMS implementation, private team training, and related services for the medical sector.