St. Louis, MO. (August 7, 2023) – Intact Genomics (IG®), a leading provider of cutting-edge molecular biology products and services, is proud to announce that it has been granted the prestigious ISO 13485:2016 certification for the design, development, manufacture and distribution of molecular biology products and services, in standard or custom format for both industries and academic institutes.
ISO 13485 is an internationally recognized standard specifically tailored for medical device manufacturers and companies involved in the design, development, production, and distribution of in vitro diagnostic (IVD) kits and reagents. The certification process involves a rigorous evaluation of a company’s quality management system, ensuring that it complies with the stringent requirements set forth by the ISO 13845 standards.
“Receiving the ISO 13485 certification is a significant milestone for Intact Genomics, ” said Dr. Chengcang Charles Wu, CEO of Intact Genomics. ” This milestone reflects the hard work and collective effort of our entire team to uphold the highest quality standards in our industry. With ISO 13485 certification, our customers can have even greater confidence in the reliability and performance of our molecular biology solutions.”
“Our team has worked tirelessly to implement and adhere to the standards set by ISO 13485,” said Dr. David Brent Halling, Leader of Protein Products Development and Laboratories Manager. “Intact Genomics’ certification to this standard proves and demonstrates to the international community that our products are made with strict adherence to traceability and quality control. This achievement reflects our unwavering commitment to delivering reliable and precise products and services for molecular biology research and diagnostics applications. It also showcases our dedication to meeting the needs and expectations of our valued customers and collaborators.”
The ISO 13485 certification further solidifies Intact Genomics’ position as a trusted partner in the molecular biology industry. The company remains committed to ongoing quality improvement initiatives, ensuring that its products and services continue to meet the evolving needs of the scientific community.
About Intact Genomics, Inc.
Established in 2013, Intact Genomics is a worldwide leader in large DNA fragment cloning and metagenomics technologies. The company continuously focuses on genomic technology innovation by applying large DNA fragment cloning related proprietary technologies in metagenomic research to develop new solutions for natural product-enzyme discovery, agricultural research, and environmental protection. Intact Genomics also provides high-quality life science products and services to help scientists explore the genome structure and function of microorganisms, plants, and animal species. We are proud to provide products and services for more than 2,000 laboratories worldwide.
Intact Genomics® and IG® are registered trademarks of Intact Genomics, Inc.
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