Congratulations to BioEngine for passing ISO 13485:2016 quality management system certification

July 2017

Shanghai BioEngine Sci-Tech Co., Ltd. received notification that it has officially passed ISO13485:2016 certification!

Scope of certification: design, development, manufacture, and distribution of culture media for in vitro diagnostic and testing reagents

The ISO 13485:2016 certification by the European Union not only proves that BioEngine can continue to provide products that meet customers' needs under a quality assurance system, but also shows that our system has reached the certification level of an internationally renowned organization. This achievement of ISO13485:2016 certification makes us more confident in product quality and safety regulations.

BioEngine will continue to take the international management level as the foundation guarantee, urge itself to make continuous progress, and strive to achieve faster, better, and more sustainable development.

The British Standards Institution (BSI) was established in 1901 and is the world's first authoritative body to implement quality certification, and the Kitemark® is a globally recognized symbol of integrity and quality. Accreditation Service (UKAS), the Netherlands Raad voor Accreditation (RvA), and the United States Registrar Accreditation Board (RAB). The ISO 13485 standard is "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.