Congratulations! | BioEngine Has Obtained ISO13485 And MDSAP Certification

In 2017, BioEngine Phase I Zhangjiang base passed ISO13485:2016 medical devices quality management system certification. Recently, after multiple stages of strict verification and audit, BioEngine Phase II Jinshan production base has successfully obtained ISO13485:2016 quality management system certification and MDSAP certification issued by BSI (British Standards Institution), which provides a solid foundation for the "Intelligent Manufacturing in China" culture media products to serve the global biopharmaceutical industry customers. As a result, BioEngine's powder culture media products meet the certification requirements for culture media in Europe and America.

Beijin Biotech is the subject of this ISO13485:2016 certification, which is the Phase II Jinshan culture media production base of BioEngine. Beijin Biotech was built according to the requirements of the ISO13485:2016 quality management system and GMP and was fully operational in 2021. It is an advanced culture medium factory with scale, informationization, and internationalization. Beijin has introduced and optimized the fully automated informalized low-temperature Cone Mixing/Pin Milling (CMPM) powder production technology. There are 5 powder culture media production lines, among which the 2600kg/batch production line is one of the large-scale production lines for manufacturing powder culture media in China, with an annual capacity of 55 million liters of powder culture media. At the same time, Beijin has also fully implemented informationization construction, supporting electronic quality systems and lean production management systems to achieve smooth, efficient, and orderly operation of production management. The successful construction of the culture media factory also provided BioEngine with the theoretical and practical basis for drafting the first association standard in China.

The acquisition of ISO13485:2016 certification and MDSAP certification is a full affirmation of BioEngine's continuous upgrade of international multi-quality system certification. BioEngine is in line with international standards, insists on strict quality control, and continues to provide domestic and international biopharmaceutical partners with high-quality and stable products and professional and reliable services to achieve win-win cooperation.

BioEngine is committed to being the most reliable animal cell culture partner in the world. In the future, BioEngine will speed up the development of the internationalization of domestic culture media products and continue to break through and surpass ourselves. We will continue to support the innovation and upgrading of animal cell culture technology to promote the high-quality development of the biomedical industry and benefit human health.

ISO 13485:2016

The ISO 13485 standard is a quality management system standard applicable to the medical device regulatory environment, and its full name is "Requirements for Medical Device Quality Management Systems for Regulatory Purposes". It adopts concepts related to PDCA based on the ISO 9001 standard. Compared to the ISO 9001 standard, which applies to all types of organizations, ISO 13485 is more specialized and focuses on organizations in industries related to medical device design and development, production storage and distribution, installation, service, and final discontinuation and disposal. The current valid version of ISO 13485 is the 2016 edition, which was officially released on March 1, 2016.

MDSAP

Medical Device Single Audit Program (MDSAP) is a set of audit procedures proposed by the International Medical Device Regulatory Forum IMDRF and endorsed and joined by the regulatory bodies of five countries: USA (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC) and Japan (MHLW). MDSAP is based on ISO13485 and combines the regulatory requirements of the five participating countries. Therefore, the MDSAP certification can meet the quality management system requirements of different countries.