Challenge: A precision medicine company needed to develop and validate an NGS-based CDx panel to support a pharmaceutical partner’s targeted therapy application under both FDA and IVDR frameworks.

Solution: MDx designed a harmonized validation approach that satisfied both regulatory pathways:

• Designed analytical and clinical validation studies
• Implemented IEC 62304-compliant software validation
• Created a unified technical documentation package

Result: Successful clinical study execution across 9 European centers, with all validation milestones achieved on time and regulatory submissions accepted by both authorities.