Regulatory & Compliance Articles

Core Issues That Terminate the MDR Conformity Assessment

Non-cormity of MDR conformity assessment stems from inadequate technical documentation, insufficient clinical evidence, and deficient QMS and risk management.

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.

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