IVDR & Companion Diagnostics: Regulations and Market Strategy
The integration of diagnostics and therapeutics is rapidly reshapi...
Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are vital for detecting diseases, cond...
Understanding IVDR Gap Assessment and Consulting Services for Medical Devices
Introduction to IVDROverview of IVDR
The In Vitro Diagnostic Regul...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publishe...
Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical process integral to...
In Vitro Diagnostic Regulation (IVDR) – General Aspects, Key features and Limitations
Introduction to IVDR:
The In Vitro Diagnostic Regulation (IVDR) re...
