Shanghai Rendu Biotechnology Co., Ltd.

Responsible for ensuring the devices are manufactured in accordance with the requirements of the Quality Management System; responsible for establishing and maintaining vigilance system; responsible for assessing feedback, complaints or incidents, and ensuring the implementation of appropriate measures.

Responsible for signing relevant declarations for devices that need to be used in clinical performance studies or other performance studies.

Responsible for drawing up and keeping up-to-date the CE technical documents and the EU declaration of conformity; responsible for verifying the regulatory compliance of devices prior to device premarket; responsible for organisation of the collection of post-market information, and drawing up, keeping up-to-date and submitting the post market surveillance (PMS) documents; responsible for device registrations and updates of EUDAMED.