Monthly Archives: February 2026

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Newsflash – Recently Harmonized Standards

  Recently, twelve standards were added to the list of harmonized standards under the EU MDR (Regulation (EU) 2017/745). The list of standards, p...

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The New Era of FDA Inspections

  As of February 2, 2026, the landscape for medical device manufacturing has officially shifted. The FDA has fully implemented the Quality Manage...