Shanghai MicroPort MedBot (Group) Co., Ltd.

Regulatory Compliance ensuring the technical documentation and the EU declaration of conformity compliance are drawn up and kept up-to-date. Regulatory Compliance ensuring investigational devices compliance.

Regulatory Compliance ensuring the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. Regulatory Compliance ensuring the post-market surveillance obligations are complied with in accordance with Article 10(10). Regulatory Compliance ensuring the reporting obligations referred to in Articles 87 to 91 are fulfilled.