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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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