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Why an EQMS is Essential for FDA Remote Regulatory Assessments

The global pandemic brought an unexpected change  – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections after it has [...]

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EU MDR & IVDR Regulation: Where Does the Guidance Stand?

Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. According to a 2022 Medical Device Coordination Group (MDCG) position [...]

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FDA Expands Medical Device Cybersecurity Draft Guidance to Stress Importance of Quality System

As innovation in medical technology increases, potential cybersecurity threats also grow. The U.S. Food and Drug Administration (FDA) expects medical device manufacturers to fully incorporate [...]

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