From August 4th to 6th, 2021, Lixin Nuokang (Shandong) Biomedical Technology Co., Ltd., a wholly-owned subsidiary of Suzhou Linaxin Biotechnology, underwent a quality system assessment for medical device manufacturing enterprises by the Shandong Provincial Food and Drug Administration. The quality system assessment of medical device manufacturing enterprises is an important method for the national drug regulatory authorities to strengthen the management of medical devices and enhance enterprise quality control. It is also one of the necessary conditions for the production and sales of Class II and Class III medical device products. The assessment of medical device quality system not only requires medical device manufacturing enterprises to have qualified hardware conditions, but also puts forward specific requirements for the qualifications of relevant personnel, and needs to have reasonable documented management procedures.

Liu Feng, General Manager of Lixin Nuokang, along with relevant personnel from the R&D, quality, marketing, and production departments, attended the audit meeting and reported to the reviewing experts on the company's preparations for the medical device production site and the products to be produced.

During the audit, the expert panel reviewed the company's production site, inspection and testing, authenticity verification of registered samples, design and development, supplier management, training and assessment, warehousing, office space, quality management, sales related documents and materials, as well as the company's qualifications.

During this process, the review team stated that the company's production order is well-organized, with high-quality inspection and testing capabilities, complete preparation of various materials, and strict and meticulous management. At the same time, the assessment team pointed out and explained the problems that still exist in the enterprise.

Lixin Nuokang was founded in accordance with the company's mission of "precision, high quality, excellence, efficiency, and integrity". It has a high standard GMP purification workshop with a capacity of 100000 levels and local 10000 levels, equipped with high-quality R&D personnel and professional production inspection personnel, and strictly adheres to the ISO13458 standard to establish a standardized quality management system.

After the review, the leaders of the Drug Administration highly affirmed the company's inspection work. At the same time, it is commendable that the company has done such an excellent job in the research and production of early screening for colon cancer in such a short period of time. Before departure, the leader of the audit team still spoke highly of the company's high-quality talent team and high-tech products; We sincerely hope that the company leaders will continue to work hard and complete the preliminary work of product launch in a relatively short period of time, quickly occupy the market, and benefit the people with cancer early screening products. The company leader stated that we will definitely achieve the planned launch of the product. Please rest assured, drug regulatory leaders.

Lixin Nuokang has passed this quality system assessment, which provides a foundation for the company's subsequent product registration, production, and sales; On the other hand, it is also an overall inspection of the company. Linaxin will strive to become stronger and develop from a higher starting point!