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Participants will gain a structured understanding of the regulatory frameworks governing medical devices and in-vitro diagnostic devices in the European Union. They will learn how device classification influences regulatory pathways and how to prepare technical documentation aligned with MDR and IVDR requirements. The program will also build knowledge of conformity assessment procedures, clinical evaluation expectations, and post-market surveillance obligations. By the end of the course, participants will be able to support regulatory strategy, ensure documentation readiness, and maintain compliance for devices entering or operating within the EU market.
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