To ensure that (a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.
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YAO Cindy
Support the primary PRRC to ensure that (a) the conformity of the devices is appropriately checked, in accordance with the QMS under which the devices are manufactured, before a device is released; (b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; (c) the post-market surveillance obligations are complied with in accordance with Article 10(10); (d) the reporting obligations referred to in Articles 87 to 91 are fulfilled.