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On February 2, 2026, FDA formally implemented Compliance Program 7382.850 – Inspection of Medical Device Manufacturers, aligned with the new Quality Management System Regulation (QMSR). This program replaces the prior inspection model that industry knew well: QSIT (Quality System Inspection Technique). For device manufacturers, regulatory professionals, and quality leaders, understanding this shift is critical. This […]
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In 2026, pharmacovigilance systems are more digital, more decentralized, and more interconnected than ever. Yet one risk continues to be underestimated across organizations — especially during inspections. It’s not always your core safety vendor. It’s the vendor that was never labeled “PV” in the first place. We’re talking about organizations that interact directly with patients […]
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