Commitment to Quality and Safety
Quality and Safety – Regulatory Compliance and Comprehensive Process Control
At Changzhou Geasure, every 3D‑printed anterior cervical plate is manufactured under ISO 13485:2016, with real‑time environmental monitoring across all ISO Class 8 cleanroom zones. Our quality system includes a 12‑step verification protocol: raw material testing (ASTM F2924 powder characterization), in‑process optical inspection (100% of layers), final dimensional CMM inspection (±0.05 mm), mechanical testing per ASTM F382 (static bending ≥400 N, fatigue at 150 N for 500,000 cycles), and sterility validation per ISO 11135.
All plates are CE marked (Class III) and FDA 510(k) cleared, supported by ISO 14001, ISO 50001, and ISO 45001 management systems. Since 2022, 100% of production lots have passed final release on first inspection, with zero implant‑related complaints reported across 350+ implanted cases.