ISO-Certified Quality You Can Trust

On July 17, 2026, Intact Genomics successfully achieved of ISO 13485:2016 recertification assessment and the renewal of its certification for the next three-year cycle. The certification covers the design, development, manufacture, and distribution of molecular biology products and services offered in standard and customized formats to industrial and academic customers worldwide.

Intact Genomics first achieved ISO 13485:2016 certification in 2023 and successfully completed its recertification in 2026. ISO 13485:2016 is a globally recognized quality-management standard for the medical-device and life-sciences industries. This achievement reflects our team’s continued commitment to quality, compliance, continuous improvement, and innovation. Through our ISO 13485-certified Quality Management System, Intact Genomics consistently delivers high-quality molecular biology reagents, customized solutions, and CDMO and OEM services that support life science research, diagnostics, and biotechnology applications.

The renewed certification further strengthens Intact Genomics’ position as a premium supplier of molecular biology reagents and a trusted partner for organizations seeking reliable products, responsive service, and quality-driven solutions.

Click here to download our ISO 13485:2016 certificate (PDF).