Manufacturing Qualification
Validated. Documented. Delivered without compromise.
Moda’s New Product Introduction (NPI) framework includes full Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) – carried out under our ISO 13485-certified quality management system.
All validation activities are aligned with FDA 21 CFR Part 820 and ISO 11139, confirming that equipment is installed correctly, processes are controlled, and production consistently meets quality requirements under real-world operating conditions.