CENTOGENE Accreditation Header

Accreditations

CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. Our ISO, CAP, and CLIA certified multiomic reference laboratories in Germany enable us to deliver precision medicine powered by Phenomic, Genomic, Transcriptomic, Epigenomic, Proteomic, and Metabolomic datasets.

Quality Driven to Achieve Scientific Excellence

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.

Furthermore, as a full-service company, we follow applicable and market-standard good laboratory practice (GLP) and good manufacturing practice (GMP) guidelines.
 

Medical Devices

Certification for In Vitro Diagnostic Medical Devices – EN ISO 13485

CENTOGENE’s quality management system meets all applicable requirements of DIN EN ISO 13485:2021 and Regulation (EU) 2017/746 of the European Parliament and of the council on in vitro diagnostic medical devices.

IVDR

Declaration for IVD Regulation (EU) 2017/746 – NGS Workflow

Declaration for IVD Regulation (EU) 2017/746 – NGS Workflow

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.

Declaration for IVD Regulation (EU) 2017/746 – Non-NGS Genotyping Workflow

Declaration for IVD Regulation (EU) 2017/746 – Non-NGS Genotyping Workflow

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.

Declaration for IVD Regulation (EU) 2017/746 – Biochemistry Workflow

Declaration for IVD Regulation (EU) 2017/746 – Biochemistry Workflow

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.

CAP

CENTOGENE CAP Accreditation Certificate PDF

College of American Pathologists CAP ISO15189

CENTOGENE is CAP accredited CAP ISO15189

College of American Pathologists Laboratory Accreditation

CENTOGENE is CAP accredited: Laboratory Accreditation Program

College of American Pathologists Proficiency Testing Participation

CENTOGENE has successfully participated in the CAP Proficiency Testing for the 2022 program year

CLIA

Centogene CLIA Accreditation PDF

Centers for Medicare and Medicaid Services – Rostock Lab

CENTOGENE received the certificate of accreditation CLIA registered #99D2049715

CMS Provider Identifier

Centers for Medicare and Medicaid Services (CMS)

CENTOGENE US LLC NPI (National Provider Identifier) number: 1386148971

NPI #1386148971

Data and Security

Information Security Management System – ISO/IEC 27001:2017 Certificate

Information Security Management System – ISO/IEC 27001:2017 Certificate

CENTOGENE's processes and IT systems are ISO/IEC 27001:2017 certified by the independent accreditor datenschutz cert GmbH, ensuring a high level of confidentiality, availability, and integrity to all processed data.

CENTOGENE Compliance Certificate Logo

PCI DSS Compliance Certification

CENTOGENE is certified as Payment Card Industry Data Security Standard (PCI DSS) compliant for protecting customers' payment card data in accordance with current requirements.

Industry

CENTOGENE Illumina Propel Certificate PDF

Illumina Propel Certification for Core and Service Labs

CENTOGENE has successfully completed certification for HiSeq 4000 System, NextSeq System and MiSeq System provided by Illumina Inc.

US State Licenses

Clinical and public health laboratory licence

California State License

CENTOGENE is licensed to operate as a clinical laboratory by the California Department of Public Health.

Pennsylvania State Permit

Pennsylvania State Permit

CENTOGENE is licensed to operate as a clinical laboratory by the Pennsylvania Department of Health.