Learn how in vitro diagnostic (IVD) devices can comply with IVDR and Indian MDR standards, ensuring regulatory alignment, ...

Under IVDR 2017/746, the Performance Evaluation Report (PER) is a critical component of the technical documentation required for CE marking of In Vitro Diagnostic (IVD) devices.

AliveDx has obtained a CE mark under the EU's in vitro diagnostic regulation (IVDR) for the AiPlex connective tissue disease ...

Under IVDR, manufacturers must generate a cumbersome amount of data, which is a real challenge in a world where clinical guidelines and best practices can change frequently and rapidly.

The IVDR framework, implemented to enhance the safety, quality, and performance of in-vitro diagnostics across Europe, introduces rigorous new requirements. Biomerica’s food intolerance products ...

Product line earns CE-marking under new EU IVDR framework – including QIAstat-Dx Analyzer, QIAstat-Dx Rise and panels for detection of gastrointestinal and respiratory infections ...

CE-marked under the EU IVDR regulation, Diagnostics.AI's platform is the first to deliver AI algorithmic transparency and per-test auditability for clinical PCR diagnostics As the May 26th CE-IVDR ...

IVDR certification is a significant regulatory milestone that validates... BOSTON and ROLLE, Switzerland, Aug. 14, 2024/ PRNewswire/-- SOPHiA GENETICS, ...

MDC Associates, a premier regulatory and clinical consulting firm specializing in in vitro diagnostics (IVDs) and medical devices, will attend ADLM 2025—the leading laboratory medicine conference ...

Inbiome Shatters Diagnostic Delays: IVDR-Certified Platform IDs Bacteria in 5 Hours Across EU Hospitals. Hours, Not Days: EU Approval Accelerates 5-Hour Pathogen ID for Critical Cases; ...