ISO 13485 is a stringent quality standard intended for organizations that produce medical devices or critical components used therein, ensuring the safety and efficacy of their products. Lexogen has been granted ISO 13485 for the research, product design, development, and production of genomic analysis solutions (kits, reagents and software). By achieving this certification, Lexogen has demonstrated its commitment to meet or exceed the legal requirements and rigorous quality standards required in the medical device industry.
"Obtaining ISO 13485 certification is a significant milestone for Lexogen," says Stéphane Barges, Chief Executive Officer at Lexogen. "This achievement highlights our unwavering commitment to providing cutting-edge biotechnology solutions, built considering the needs of our customers, that meet the highest quality standards. It reinforces our position as a trusted partner in the industry and demonstrates our dedication to customer satisfaction."
Lexogen's ISO 13485 certification further strengthens the company's ability to serve the growing demands of its customers, including researchers, biotech, and pharmaceutical companies as well as IVD manufacturers.
Lexogen's pledge to continuous improvement, risk and quality management extends beyond the ISO 13485:2016 requirements since the company is also certified to ISO 9001:2015.
Established in 2007, Lexogen is a leading company in transcriptomics, next-generation sequencing, and RNA analysis. The mission of the Lexogen team is to empower their customers with innovative top quality RNA analysis solutions and support. Lexogen is the inventor of 3' RNA sequencing, a unique technology proven for its efficiency, robustness, and sensitivity, especially unmatched for differential gene expression analysis. Lexogen's proprietary portfolio includes innovative kits for true single-cell as well as bulk RNA sequencing, RNA extraction, ribosomal RNA depletion, spike-in RNA variant controls, and nascent RNA labeling for transcriptome-wide analysis of RNA kinetics. Lexogen also provides first-class, fully integrated NGS services from experimental design to analytical reporting. Lexogen is a privately held company, headquartered in Vienna, Austria with a subsidiary in New Hampshire, USA.
To learn more, visit www.lexogen.com and follow @lexogen.
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