ANKON Technologies Co., Ltd.

Before releasing the device, ensure that the device is produced in accordance with the requirements of the corresponding quality management system, and that the compliance of the device and regulations should be properly checked.

Organize the preparation of CE technical documents and keep them up to date. Ensure that the relevant declaration of the device to be clinically tested has been signed. The statement includes: the tested device meets the basic safety and performance requirements;

Ensure that the post-market surveillance (PMS) work is organized in accordance with the requirements of the regulations. Responsible for the overall arrangements for the report, investigation and handling of medical device accidents, and submit a warning system report to the competent authority of the country where the accident occurred.

CE registration and regulatory management of medical device products