Product Quality and Compliance

Ventana Digital Pathology, powered by BioImagene has established quality management systems designed to meet and exceed the requirements of stringent standards in the in vitro diagnostics industry:

International Standards:
ISO 13485:2003 Medical Devices - Quality Management Systems

Canada:
ISO 13485:2003 CMDCAS Medical Devices - Quality Management Systems

United States of America:
21CFR Part 820 Quality System Regulation