n6 Achieves ISO 13485:2016 Certification, Strengthening the Quality Foundation Behind iconPCR™ Instruments

Intertek registration of n6's quality management system covers the manufacture and service of instrumentation for genetic research

PLEASANTON, Calif., Oct. 16, 2026 /PRNewswire/ -- n6 Tec, Inc. ("n6"), maker of intelligent NGS library prep instruments, today announced that its quality management system has been certified to ISO 13485:2016 by Intertek, a leading global quality assurance provider. The certification applies to the manufacture and service of instrumentation for genetic research at n6's Pleasanton, California headquarters.

ISO 13485:2016, "Medical devices — Quality management systems — Requirements for regulatory purposes," is the internationally recognized standard for quality management systems in organizations that design, manufacture, and service medical devices. Certification requires an independent auditor to verify that documented processes for design controls, supplier management, manufacturing, traceability, corrective and preventive action, and customer feedback are in place and are followed.

n6 received its initial certificate, number 0259003, on October 12, 2026. The certificate is valid through October 11, 2029, subject to ongoing surveillance by the certification body.

What this means for customers:

• Consistent instruments, release after release. Controlled design, manufacturing, and service processes support repeatable performance of iconPCR-based instruments, including the icon16 and the high-throughput icon96 system, and their AutoNorm adaptive amplification workflows.
• Traceability and responsiveness. Documented complaint handling, corrective and preventive action, and field service procedures give laboratories a clear path when questions arise.
• Confidence for regulated and quality-minded labs. Genomics cores, biopharma teams, and translational research groups that audit their suppliers can point to an independently verified quality system.
• A foundation for what comes next. A certified quality system is a recognized building block for organizations that plan to serve more regulated markets.

"Customers trust our instruments with irreplaceable samples, so how we design, build, and support them matters as much as what they do. ISO 13485 certification is an independent confirmation that quality is built into every step at n6. It gives our customers and distribution partners confidence that the instruments they rely on today are backed by a system committed to the highest quality standards," said Pranav Patel, CEO of n6.

iconPCR with AutoNorm combines real-time amplification, quantification, and normalization in one automated step to produce sequencing-ready NGS libraries with more consistent, higher-quality data. It supports sample types such as FFPE tissue, cfDNA, and microbiome samples, and applications including whole-genome sequencing, RNA-seq, small RNA, 16S profiling, and drug discovery workflows. n6 instruments are used by customers and distribution partners in more than 25 countries.

To learn more about n6's ISO 13485-certified instruments, visit their product page.

About n6
n6 builds intelligent NGS library prep instruments that combine real-time thermocycling with AutoNorm software to deliver normalized, sequencing-ready libraries in one automated step. Icon16 and the high-throughput system icon96 instruments are used by genomics cores and research teams across fields as diverse as metagenomics, oncology, and multi-omics research. n6 is headquartered in Pleasanton, California. For more information, visit n6tec.com.

Trademarks
iconPCR and icon96 are trademarks of n6 Tec, Inc. n6 products are for research use only and not for use in diagnostic procedures.

SOURCE n6 Inc.