Challenge: LDT to IVDR transition + CE mark for an NGS Clinical Exome Sequencing (CES) panel targeting over 4000 genes
Solution: Full technical documentation development for NGS, bioinformatics pipeline, 13485 QMS implementation and notified body submission
Result: CE mark granted in 16 months, enabling the client to become one of the very few laboratories globally to certify such a comprehensive gene panel under IVDR