IVD & Lab Instruments

FDA Tightens IVD Import Filing From October 2026

FDA Tightens IVD Import Filing From October 2026: learn how new eCTD v6.3, clinical validation, and translation requirements may impact U.S.-bound IVD shipments, filing speed, and compliance readiness.

Clinical Laboratory Automation Systems: When Automation Improves TAT and Staffing Efficiency

Clinical laboratory automation systems can improve TAT, reduce manual bottlenecks, and boost staffing efficiency. Discover how to choose the right fit for your lab workflow.

How to Compare High Throughput Clinical Analyzers by Throughput, Menu, and Downtime

High throughput clinical analyzers compared the right way: evaluate real throughput, assay menu, and downtime to find reliable systems that improve lab efficiency and ROI.

Saudi SFDA Sets CPVR Pre-Submission Rule for IVD Reagents

Saudi SFDA sets a CPVR pre-submission rule for IVD reagents from August 1, 2026. Learn how ISO 20945:2021 impacts registration, compliance costs, timelines, and Saudi market access.

FDA Tightens IVD Cold-Chain Import Requirements

FDA Tightens IVD Cold-Chain Import Requirements: learn how the new 2–8C rule and e-temperature log mandate affect packaging, customs clearance, shipment timing, and compliance risk.

PCR Molecular Diagnostic Instruments: Key Specs That Affect Test Accuracy

PCR molecular diagnostic instruments directly impact test accuracy through thermal control, optical precision, contamination prevention, and traceable software—see which specs matter most before you buy.

FDA Sets IVD Batch QR Label Rule for Oct. 2026

FDA Sets IVD Batch QR Label Rule for Oct. 2026: learn how the new UDI-DI and batch QR code mandate affects IVD exports, packaging compliance, customs clearance, and U.S. market access.

FDA Revises IVD Label Rules for October 2026 UDI Traceability

FDA revises IVD label rules for October 2026 UDI traceability, requiring UDI-DI and batch QR codes on smallest saleable units. Learn the compliance impact on labels, packaging, ERP, and U.S. exports.

FDA Sets New IVD Label Rules for October 2026

FDA Sets New IVD Label Rules for October 2026: learn how UDI-DI and batch-level QR code requirements will affect IVD labeling, exports, packaging, and U.S. market compliance.

How Automated Molecular Testing Systems Improve Lab Turnaround Time

Automated molecular testing systems help labs cut turnaround time by reducing manual steps, improving workflow consistency, and speeding reporting. Discover how to boost efficiency.