Challenge: A US laboratory sought to CE mark their NGS clinical exome sequencing panel targeting over 4,000 genes under IVDR.

Solution: MDx developed complete technical documentation for the NGS workflow and bioinformatics pipeline, implemented ISO 13485 QMS, and managed the notified body submission process.

Result: CE mark granted in 16 months, enabling the client to become one of the few laboratories globally to certify such a comprehensive gene panel