Epigenomics operates under a quality management system which is ISO 13485 certified for the design, development, manufacturing and distribution of in vitro diagnostic (IVD) products. ISO 13485 is an internationally recognized quality management standard developed for medical devices by the International Organization for Standardization (ISO), a world-wide federation of national standards bodies. The ISO certificate demonstrates the successful implementation and use of a quality management system that conforms to the international quality management standard for medical devices that also includes IVD products such as Epigenomics’ diagnostic products for cancer.

The ISO 13485 certification reflects Epigenomics strong commitment to quality, which is further described in Epigenomics' Quality Policy:

“We are committed to bringing high quality cancer molecular diagnostic products to the market, which are safe and effective for their intended uses. In order to consistently provide products that meet customer requirements, we continuously improve our quality system to maintain product conformity, regulatory compliance and optimal business practices. We ensure that all employees are aware of this quality policy through prescribed presentation and discussion of the policy. The requirements of our quality system, as detailed in our quality manual, quality procedures and quality objectives, apply to all employees and facilities involved in the design, development, manufacturing and distribution of our in vitro diagnostic products.”

Epigenomics AG
Quality Management
Phone: +49 30 24345-0
contact@epigenomics.com

Certificate