Certifications & Accreditations
OncoDNA: Quality environment for testing
ISO 15189
Testing activities from our subcontractor lab (and shareholder), IPG, are performed under ISO 15189:2012 (accredited lab since 06/2009). ISO 15189 is an international standard that specifies the quality and competence management system requirements particular to medical laboratories.
CLIA / CAP
OncoDNA’s laboratory in Evry is CLIA certified (Clinical Laboratory Improvement Act) and CAP accredited (College of American Pathologists) to reinforce its global clinical trial testing services.
GCP – Good Clinical Practice
OncoDNA is compliant with the Guideline for Good Clinical Practices of the International Conference on Harmonization (ICH GCP E6 R2) for the services provided to its customers. OncoDNA has been audited several times over the years to demonstrate its compliance.
ISO 13485
OncoDNA has a certified Quality Management System in place based on the standard ISO 13485:2016 Quality Management Systems – Requirements for regulatory purposes, covering the design, the development and the servicing of our in vitro diagnostic products.
GDPR - General Data Protection Regulation
Compliance to GDPR is a central preoccupation for OncoDNA and is supervized by our internal DPO. This compliance ensures greater patient and oncologist confidence in privacy, keeping data subjects’ personally identifiable information secure, improved data security and increased alignment with evolving technologies.
ISO 27001
OncoDNA is implementing ISO/IEC 27001:2022, after having successfully implemented the 2013 version of the norm in 2017. It will cover requirements for Information Security of our applications and Medical Device Software (MDSW).
