Qingdao Boyite Biomaterials Co., Ltd. is a growing national high-tech enterprise, mainly engaged in the research and development, production, sales and service of high-end products of marine biological medical materials, especially in the innovation of chitin/chitosan medical materials has achieved outstanding results.
Wonderful case
Chitosan group absorbs hemostatic nonwovens,
Large trauma first aid hemostatic powder
The company's original main product chitosan group can absorb hemostasis nonwovens (Shuyi yarn, three types of equipment), is the national "Eleventh Five-Year" marine 863 project landing products, hemostasis function and safety is better than the United States Johnson & Johnson similar products, reached the international leading level, the product has been listed for 6 years to sell more than 1 million pieces, no adverse reactions.
Large trauma emergency hemostatic powder (three types of equipment), is the national "Twelfth Five-Year" 863 research support project, in the PLA General Hospital and other military hospitals to complete clinical trials, the performance is better than the US military Celox hemostatic powder, the product has been sent to the State Food and Drug Administration for approval, intends to jointly tackle key problems with the army to achieve our army's installation.
Accompanying services to help enterprises develop
Jiang Huiping, the manager representative of Qingdao Boyite Biomaterials Co., Ltd.:
"The staff of the Laoshan District Market Supervision and Administration Bureau often actively visits and communicates with the enterprise to understand the actual difficulties of the enterprise, designate a special person to guide the legal and compliant production and operation of the enterprise, and improve the company's control level of medical device quality." At the same time, it also provides continuous tracking services for the product items that the company needs to register, interprets the relevant approval policies for medical devices for the enterprise, assists the company's chitosan hemostatic sponge, chitosan hemostasis granules and other products to quickly obtain product registration certificates and production licenses, and promotes the company's projects to land and list as soon as possible. ”
The level of quality management continues to improve
The company has a national three-class medical device production license, in accordance with the EU standards to design and build GMP production workshop of 12,000 square meters. The quality management system has passed EN ISO13485, ISO 9001 certification, and passed the on-site inspection of THE CE notified body BSI.
"Industry-university-research" has become a model
The company and scientific research institutes collaborative research and development and innovation, has achieved a number of leading scientific research results at home and abroad.
He has completed 7 national science and technology projects, obtained 7 national invention patents, 1 international invention patent, and won a number of scientific and technological awards at or above the provincial and ministerial levels such as the second prize of national scientific and technological progress.
The company also undertakes the research and practice functions of a number of academic and industry institutions, and is the joint innovation research base of marine biological medical materials of the National Biomedical Materials Engineering Technology Research Center, the initiating unit and practice base of the Marine Biological Materials Branch of the Chinese Society of Biological Materials, the Qingdao Marine Biological Medical Materials Engineering Research Center, the enterprise postdoctoral workstation and the Qingdao Medical Device Production Supervision Practice Base.
High-end innovative medical device products under development
First, chitosan-based fully degradable vascular stents have been evaluated in porcine coronary artery implantation at the National Cardiovascular Disease Center, and good phased test results have been obtained, and it is the only marine biological material fully degradable vascular stent at home and abroad.
The second is chitosan-based induction regeneration of small-caliber artificial blood vessels, and innovative results have been achieved in animal model tests.
The third is to take the marine source chitin/chitosan substrate as a breakthrough to carry out risk management research on the whole life cycle, provide data support for the scientific research of medical device supervision, and contribute to the development of the national scientific supervision system.