The partnership combines I3CGlobal's regulatory expertise with Reghelps SRC CRO’s capabilities to streamline IVD Performance Evaluation and CE certification. I3CGLOBAL partners with Reghelps SRC CRO ...

FALLS CHURCH, Va., May 19, 2020 /PRNewswire-PRWeb/ -- Implementing Clinical and Performance Evaluation Reports for Your Medical Device Best Practices for Getting them Right An FDAnews Webinar Tuesday, ...

IVDR Consultancy by I3CGLOBAL expands to help global IVD manufacturers achieve CE Marking compliance under EU IVDR 2017/746 efficiently. NEW DELHI, DELHI, INDIA ...

First-and-only test of its kind approved under new European Union regulations expands access to personalized cancer care for patients across the EU This in vitro diagnostic (IVD) assay, which has been ...

Qiagen (QGEN) “announced that it has achieved CE-IVDR certification for its full portfolio of QIAstat-Dx syndromic testing systems and panels, including an expanded Meningitis/Encephalitis (ME) Panel ...

SAN JOSE, Calif., July 28, 2022 /PRNewswire/ -- OptraSCAN® a leading end-to-end digital pathology solution provider, announced that it has received CE-IVDR marking for the OS-Ultra™ scanners, its high ...

First central lab in EU to perform this blood-based assay under IVDR/LDT regulations, supporting inclusion and exclusion criteria in Alzheimer’s clinical trials Achieving IVDR validation for the ...