Regulatory & Compliance Articles

FDA Transition to ISO 13485: Regulatory Impact

The FDA transition to ISO 13485 is a significant step in streamlining medical device manufacturers’ quality management systems for international operations.

FDA Regulatory Reform Outlook 2023

FDA Regulatory Reform Outlook 2023 focuses on the significant changes to the FDA regulatory framework and several initiatives that are waiting on the horizon.

FDA Regulatory Reform Outlook 2023

Aug 29, 2023 | Regulatory & Compliance

2023 Briefly In recent years, the US Food and Drug Administration (FDA) has faced criticism regarding its review...

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