MGI gene sequencing company

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Standard

MGI is well-established in the product certification qualification system. As a major global company of the industry, it also plays an important role in leading industry standards.


Since its establishment, many products of MGI were the first to receive approval for use in the market. For example, DNBSEQ-T7 was the first to receive emergency approval from the National Medical Products Administration during the epidemic,and MGIUS-R3 became the first remote ultrasonic equipment approved for listing.


1. MGI has received a number of international accreditations including ISO 16485 Medical Device Quality Management System, ISO 14001 Environmental Management System, ISO 27001 Information Security Management System, and ISO 45001 China Occupational Health and Safety Management System.


2. MGI's products have received more than 110 national and international certifications, including National Medical Products Administration (NMPA, China), and international certifications such as CE, CB, cTUVus, EAC. The products have met the market entry requirements in most major markets including Asia Pacific, EU, America, Russia, and Central Asia, Japan, South Korea, Australia, Saudi Arabia, Brazil, and Africa.


3. MGI contributed to the formulation and publication of 41 national standards and industry guidelines including the world’s first Standard for High-throughput Genetic Sequencers, the industry's first Group Standard of COVID-19 Diagnostics by Remote Robotic Ultrasound Systems, the sequencing industry's first Group Standard of Genetic Assembly Quality Assessment, China’s first Group Standard of Blockchain-based Genetic Data Service Applications, High-throughput Sequencing Data Sequence Format Specifications, and "Next-generation-Sequencing-based HPV Genotyping Detection Standard". MGI contributed to the formulation of 6 national standards, 2 industry standards, 7 enterprise standards, 24 group standards and 2 Belt and Road regional standards to actively promote the establishment of industry standards.
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