Shanghai BioEngine Sci-Tech Co., Ltd: the first EU BSI. ISO13485:2016 certified culture media manufacturer in China

Recently, BioEngine has successfully passed the EU BSI. ISO13485:2016 quality management system certification and officially received the certificate issued by BSI, becoming the first medium manufacturer in China to receive this certification. The scope of the EU ISO13485:2016 certification covers the design, development, manufacture, and distribution of culture media.

The successful acquisition of BSI. ISO13485:2016 quality management system certification is the result of Bechtel's philosophy of positioning itself to meet international quality management standards, which is not only a confirmation of the company's existing management system but also an important milestone in BioEngine's development process. This marks that BioEngine has stepped on the track with the international enterprise management level and can assure customers that all aspects from product design and development to production are strictly controlled and traceable to ensure the stable quality of culture media.

BioEngine will continue to strive for excellence and become a reliable culture media manufacturer with international management as the foundation guarantee.

About BSI

British Standards Institution (BSI), established in 1901, is the world's first authoritative body to implement quality certification, and the kite mark Kitemark® is a globally renowned representative of integrity and quality. Kingdom Accreditation Service (UKAS), the Netherlands Raad voor Accreditation (RvA), and the United States Registrar Accreditation Board (RAB). Among them is the ISO 13485 standard "Medical devices - Quality management systems - Requirements for regulatory purposes" (Medical devices - Quality management systems - Requirements for regulatory purposes), which has become the global standard for companies engaged in the manufacture of medical devices. It has the status of a major medical device notified body in the EU.

About BioEngine

Ltd., located in Pudong Zhangjiang Hi-Tech Park, is a biotechnology company integrating R&D, production, sales, and services, mainly engaged in the innovative R&D and application services of large-scale high-density serum-free culture technology for animal cells, providing technical services and key services for the pilot incubation, industrialization, and production of biomedical products such as antibodies, recombinant proteins, human and poultry virus vaccines, cell therapy, and human tissue engineering. We provide technical services and key raw materials and equipment for the incubation, industrialization, and production of biopharmaceutical products such as antibodies, recombinant proteins, livestock and poultry virus vaccines, cell therapy, and human tissue engineering.

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