Joana Gomes

2 min read

Implications of FDA’s Quality Management System Regulation (QMSR) Final Rule

On February 2, 2024, the Food and Drug Administration (FDA) issued a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System Regulation (QSR). The final rule is effective February 2, 2026.

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2 min read

New Proposal for Extended Transition Periods for IVDs: Can Manufacturers Slow Down Transition Efforts? 

The EU Commission recently published (January 23, 2024) a new proposal for amending the regulations EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming...

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