Guangdong Victory Biotech Co., Ltd. and Wuzhou Victory Biotech Co., Ltd. have officially received the ISO 13485 and ISO 22442 certifications issued by DNV for their new factories.
The ISO 13485 audit of Wuzhou Victory Biotech, conducted by DNV, confirms that the company is well-prepared for the manufacturing of hydrogel wound dressings and bone graft substitutes.
The new facility in Foshan has been completed as part of the development strategy. This facility will focus on the research, development, and manufacturing of Class III medical-grade collagen.
The DNV audit has been successfully completed. Guangdong Victory Biotech passed the periodic ISO 13485 audit and was certified for the manufacturing of bovine collagen in accordance with ISO 22442.
The new clean room facility in Wuzhou has been completed as part of business expansion. This facility adheres to international standards and will be used for the manufacture of medical-grade collagen products (Class I and Class III).
The in vivo and in vitro clinical studies of collagen wound dressings have been completed.
Shenguan Investment Development Co., Ltd. has been introduced as a new shareholder. Victory Biotech has received significant support in collagen-related technology and resources.
The mass production line is now operational, and preclinical and clinical testing for six products has been initiated.
Victory Biotech has successfully passed the annual ISO 13485 audit and obtained the exclusive ISO 22442 certification in China for the manufacture of bovine collagen in accordance with EN ISO 22442-1:2007, EN ISO 22442-2:2007, and EN ISO 22442-3:2007.
The Clean Room (manufacturing workshop) was constructed with the support of technical advisors from the Principal Research Scientist of the Commonwealth Scientific and Industrial Research Organisation (CSIRO) and National Taiwan University (NTU).