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The challenges of placing medical devices on the European market are addressed in the video tutorial on the Medical Device Regulation (MDR). This regulation has raised standards for manufacturers, importers, and distributors. The video aims to help viewers understand the European legal framework and the necessary steps to take before selling devices in Europe. The presenter, Kazan Yuna, offers a checklist at the end to ensure compliance with regulatory requirements and streamline the marketing process. Kazan Yuna, owner of Yuna Institute, a consultancy firm, emphasizes the importance of establishing quality management systems and conducting usability tests for medical device manufacturers.
