Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are vital for detecting diseases, con...
Understanding IVDR Gap Assessment and Consulting Services for Medical Devices
Introduction to IVDROverview of IVDR
The In Vitro Diagnostic Regu...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publish...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) r...
Using Benchmarks to Show Compliance EU MDR and EU IVDR
Benchmarking is a formal procedure of evaluation in a process or ...
IVDR Performance Evaluation: An Executive Overview
In vitro diagnostic (IVD) devices are essential component of mode...
