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Mar 31, 2025

Less Than A Year to Go! FDA’s New Quality Management System Regulation (QMSR) Is Getting Closer

Pre oxygenation for general anesthesia

Mar 11, 2025

Navigating the Impact of EU Regulation 2024/1860 on Medical Device and IVD Manufacturers

Software as Medical Device

Mar 06, 2025

Navigating the Top 6 Medical Device Compliance Issues in the Next 12 Months

Feb 28, 2025

PLAN. RISK. CAPA. The Most Important Four-Letter Words in Any Medical Device QMS

Software as Medical Device

Feb 24, 2025

Compliance Requirements for Medical Device Software and Software as a Medical Device (SaMD) in the US and EU

Jun 27, 2024

FDA QSR vs. QMSR: What Medical Device Manufacturers Need to Know