QIAGEN receives European IVDR certification for QIAGEN Clinical Insight Interpret, its medical device software for clinical decision support
QIAGEN announced an updated version of its clinical decision support platform, QIAGEN Clinical Insight Interpret for NGS molecular profiling of hereditary and somatic diseases, has received the European Union (EU) Technical Documentation Assessment and Quality Management System certificate under the European In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR).
QIAGEN Clinical Insight Interpret is certified under IVDR for both oncology and hereditary applications. As a medical device software for clinical decision support (Class C IVD Medical Device) it conforms with regulatory policy. The updated certified version will be available for customers in Europe later in 2024, depending on requirements for sale in respective countries.
QIAGEN Clinical Insight Interpret for tertiary analysis that can be used with any validated panel and sequencing platform. It provides variant annotation, classification, interpretation and reporting of somatic and germline next-generation sequencing (NGS) tests.
QIAGEN Redwood City, the development site of the QIAGEN Clinical Insight Interpret platform, has ISO 13485:2016 certification for its Medical Devices and Quality Management Systems based on the QIAGEN Clinical Insight Interpret product.
More information about QIAGEN Clinical Insight Interpret can be found at https://digitalinsights.qiagen.com/products-overview/clinical-insights-portfolio/qiagen-clinical-insight/qci-interpret/.
