Is the biochemical inspection work of medical device company good?
Yangzhou Huaxing Medical Device Industry Co., Ltd. is a professional manufacturer of disposable medical device products, located in Touqiao Town, the eastern suburb of Yangzhou, a beautiful historical and cultural city. Founded in 1995, the company mainly produced disposable sanitary materials in the early days. Under the leadership of Chairman and General Manager Mr. Li, after 10 years of hard work, the company has become one of the leading enterprises in Yangzhou medical industry with excellent product quality and enthusiastic service. The company now covers an area of 33 mu, with a production area of nearly 6,000 square meters and a storage area of nearly 2,000 square meters. In terms of production workshops,100,000 purification workshop covers more than 2,000 square meters, and 10,000 purification workshop covers 600 square meters. At the same time, it also has a high-demand sterile 100-grade purification workshop, which is specially used for the production of the company's new product absorbable suture. At present, the company mainly produces two or three types of medical devices. The main products are: disposable anesthesia puncture kit, anesthesia analgesia pump, electronic infusion pump, thoracic puncture kit, general anesthesia kit and absorbable surgical suture. In order to meet the needs of the increasingly standardized medical market and the upcoming GMP specification for medical devices, the company strictly refers to the experience and standards of pharmaceutical manufacturers in workshop design and related supporting facilities, and organizes and implements the construction of purification workshop with a high starting point and strict requirements. Purification workshop can maintain a high level of production technology in the next five to ten years. In order to ensure the product quality of the enterprise, the company has gradually invested in purchasing testing instruments since 2000, and gradually established a complete testing center. At present, the testing center of the company can complete the incoming inspection, process inspection and ex-factory inspection of all products of the company. Excellent detection ability provides a strong guarantee for product quality control. At the same time, in order to improve the company's management ability, the company actively promotes and implements the advanced ISO900 1 quality management system, and equips the company's daily management according to the advanced management requirements. At present, the management level and quality of the company's existing managers have been greatly improved. At present, the company has hired two medical device engineers to guide the company's production and operation. There are 1 undergraduate students and 5 junior college students in the management team. Through hard work, the company successfully passed the professional system certification of National Medical Device Huaguang Medical Device Certification Co., Ltd. in April 2004. Since the State Food and Drug Administration implemented the market sampling inspection system for key products in 2003, more than 20 batches of disposable anesthesia puncture kits and disposable infusion pump products have passed the sampling inspection, and all the main indicators are qualified.