CENTOGENE follows the strictest quality criteria to meet our customer’s requirements in clinical diagnostics, clinical trial services, and research and development.
This is supported by CENTOGENE’s multi-discipline quality management system (QMS), which is recognized by our ISO, CAP, and CLIA certifications. CENTOGENE’s QMS is integrated into every aspect of our operations, spanning from data integrity and privacy to scientific research and innovations.
CENTOGENE’s quality management system meets all applicable requirements of EN ISO 13485:2021 and Regulation (EU) 2017/746 of the European Parliament and of the council on in vitro diagnostic medical devices.
CENTOGENE declares under our sole responsibility that our Biochemistry workflow (IVD system) manufactured by us by way of in-house production complies with all requirements of the IVD Regulation (EU) 2017/746.
CENTOGENE declares under our sole responsibility that our NGS workflow (IVD system) manufactured by us by way of in-house production complies with all requirements of the IVD Regulation (EU) 2017/746.
CENTOGENE declares under our sole responsibility that our Non-NGS genotyping workflow (IVD system) manufactured by us by way of in-house production complies with all requirements of the IVD Regulation (EU) 2017/746.
CENTOGENE is CAP accredited: Laboratory Accreditation Program
CENTOGENE received the certificate of accreditation CLIA registered #99D2049715
CENTOGENE is licensed to operate as a clinical laboratory by the California Department of Public Health.
CENTOGENE is licensed as a clinical laboratory by the Maryland Department of Health.
CENTOGENE is licensed to operate as a clinical laboratory by the Pennsylvania Department of Health.
CENTOGENE is licensed as a clinical laboratory by the Rhode Island Department of Health.
CENTOGENE is certified as Payment Card Industry Data Security Standard (PCI DSS) compliant for protecting customers’ payment card data in accordance with current requirements.
CENTOGENE has successfully completed certification for HiSeq 4000 System, NextSeq System and MiSeq System provided by Illumina Inc.
