Quality Control
The quality management of Zhongde Yunsheng hearing aids is based on the "Quality Management Specification for Medical Device Production", YY/T 0287-2017/ISO13485:2016 "Quality Management System for Medical Devices - Requirements for Regulatory Purposes", and GB/T 19001-2016/ISO 9001:2015 "Quality Management System Requirements" standards. The design, development, production, sales, and after-sales service processes of the product are all carried out in accordance with standard requirements.
The quality control of medical device products produced by Zhongde Yunsheng during the life cycle and the process stipulated by medical device product regulations are applicable to both internal and external (including certification bodies) evaluations and verified of our company's ability to stably provide products that meet customer and applicable legal and regulatory requirements. Through effective operation and continuous improvement of the system, to ensure compliance with customer and applicable legal and regulatory requirements, and to enhance customer satisfaction.
In order to let users understand the quality of their use, they can check the "Test Report" in the "My" - "My Hearing Aid Quality Profile" section of the "Zhongde Yunsheng" mini program.
