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This course provides a comprehensive introduction to the European regulatory framework governing medical devices. Designed for professionals in the medical device industry, it covers key aspects of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Participants will learn about device classification, conformity assessment procedures, CE marking, post-market surveillance, and the role of notified bodies. The course emphasizes compliance, risk management, and documentation requirements to ensure products meet EU standards. Ideal for regulatory affairs specialists, quality managers, and manufacturers seeking to bring medical devices to the European market.

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4.6
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