Nanodigmbio Biotechnology has obtained the ISO13485:2016 quality management system certification

View: 1919 / Time: 2021-08-17

The raw materials of molecular diagnostics from Nanodigmbio Biotechnology have recently obtained the ISO13485:2016 quality management system certification awarded by National Quality Assurance.
This indicates that Nanodigmbio Biotechnology can offer high-quality products in the field of medical apparatus and instruments in the long term, and reach the international level in product designing, manufacturing and marketability.
Nanodigmbio Biotechnology will stand firm for supplying IVD raw materials with high quality.


About ISO 13485

ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

About Nanodigmbio

Nanodigmbio believes in Nano Trans More, dedicated to creating more value and serving diagnosis in the field of targeted sequencing. Nanodigmbio is committed to providing specialized and high-quality products and ready-for-use solutions for academic institutions, medical institutions, NGS industrial companies etc.Nanodigmbio has complete series of products in targeted sequencing, including kinds of library preparation kits and liquid phase hybridization reagents, compatible with MGI and illumina platforms. Nanodigmbio provides optimized panels for applications in precision medicine and research, including exome research panel, pan-cancer research panel, hemooncology research panel and respirovirus research panel, and excellent customized panel validated by NGS. Nanodimbio owns a R&D center of over 2,000 m2 and a GMP manufacturing facility (YY/T0287-2017idt ISO13485:2016) of over 2,500 m2, ensuring high innovation R&D and production. The sales network of Nanodigmbio has covered all over the China and is expanding to overseas markets. We are honored to grow together with global customers and do our best to satisfy all demands on high-quality targeted sequencing solutions and related IVD materials.