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...
Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical process integral t...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) r...
General Safety and Performance Requirements (GSPR)
What is GSPR?        The GSPR is known as General Safety and Per...
