1)Ensure to establish, record, implement and maintain the updated and continuously improving quality management system. 2)Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.3)Ensure the post-market surveillance (PMS) activities compliance with Article 10 (10) in MDR, and ensure the implementation of PMS activities and keep up-to-date. 4)Perform the duties including reporting obligation referred to in Article 87 and so on.
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Cartography of Shanghai TeleCardio MedTech Co., Ltd.