Challenge: Major EU cancer center needed to maintain NGS-based LDTs under IVDR while continuing pharma trial partnerships.
Solution:
- Implemented Article 5(5) justification framework
- Developed GSPRs & technical documentation under IVDR
- Integrated ISO 15189 with 13485 and IVDR-compliant PMS
Result:
All tests maintained with zero service interruption. The laboratory was allowed to continue offering local tests in clinical trials.
