In order to further standardize the operation of the company's quality management system and products, enhance the independent innovation ability of the company's employees, and improve the company's international and domestic market competitiveness and brand influence, German Rhine certification company carried out CE audit and ISO13485 quality management system renewal audit on our company from June 21 to 22, 2021.

Headquartered in Cologne, German Rhein group has 490 branches in 61 countries around the world. Founded in 1872, Rhein group is a global company providing certification and testing (conformity assessment) services and has far-reaching influence in the industry.

In two days, the person in charge of Ruxin introduced the company's overall situation and business development status to the certification team. At the same time, three teachers from Rhein certification company of Germany conducted rigorous and detailed audit on the operation of our company's quality management system, products and technical documents by observing the site, checking the document records and interviewing.

This CE on-site audit includes the quality management system certificate renewal audit, and is applicable to the requirements of Article 120 of the new MDR regulation during the transition period. In order to ensure the smooth development of the audit, before the audit, all employees of the company make joint efforts to learn the latest regulations and policies through searching materials and documents, and actively implement the theoretical knowledge into the quality management system, which also lays a solid foundation for the implementation of the follow-up MDR new regulations; During the audit process, we fully cooperated with the needs of the audit expert team and successfully completed a serious and professional audit.

The TÜV Rheinland team did not issue unqualified items to our company's audit results. After careful preparation in the early stage and active cooperation in the audit process, Ruxin successfully passed the on-site audit.

Last this meeting, the leaders of the company expressed their gratitude for the professional and rigorous audit of the audit team teachers of TÜV Rheinland, and asked all departments to carry out targeted rectification on the observation items proposed by the audit teachers, continuously improve our quality management system and product technology level, and lay a solid foundation for opening the EU market and going to the world in the future.