Quality is the substrate. Not the output.
Our quality management system is built on the principle that the only acceptable level of defect in a Class III implant is zero. Every step of the patient-data-to-implant pipeline is validated, traceable, and auditable.
Dual-certified. Continuously audited.
GMP
Production of Class III medical devices
ISO 13485
Quality management for medical devices
NMPA Class III
国械注准 20263130176
CE-MDR
Class III, Rule 8
Five pillars. One promise.
Traceability
Every implant is traceable to its patient dataset, powder lot, build cycle, post-processing cell, inspector, and shipment. Full genealogy for the entire life of the product.
Validation
Process validation per ASTM F3301, FEA per ASTM F382, packaging per ISO 11607, sterilisation per ISO 11135, surface per ASTM F86. All methods qualified; all equipment calibrated.
100% Inspection
Every implant is CMM-inspected. Every implant is CT-scanned against its design STL. Statistical process control on every machine, every shift, every lot.
CAPA & Post-Market
Active post-market surveillance. Every complaint investigated within 24 hours. CAPA loop closed with quantified effectiveness checks. Field safety corrective actions per MDR Article 87.
Risk Management
Full ISO 14971 risk management for every product. FMEA updated with each design change. Benefit-risk continuously evaluated against post-market data.
Clinical Follow-Up
PMCF studies per MDR Annex XIV. Real-world evidence collected from 500+ partner hospitals. Database continuously feeds back into design and process improvements.
Mapped to every relevant international standard.
From material chemistry to packaging integrity, every step of our process is anchored in the most rigorous international standards.
| Standard | Title | Scope |
|---|---|---|
| ASTM F136 | Wrought Ti-6Al-4V ELI for surgical implants | Material chemistry |
| ASTM F3301 | Additive manufacturing of metallic medical implants | Process & material |
| ASTM F3434 | Guide for AM of metallic medical implants — characterisation | Characterisation |
| ASTM F86 | Surface passivation of metallic surgical implants | Surface finishing |
| ASTM F382 | Metallic bone plates — mechanical test methods | Mechanical testing |
| ISO 5832-3 | Titanium alloys for surgical implants — Ti-6Al-4V | Material — international |
| ISO 9585 | Bending & torsion fatigue of bone plates | Mechanical fatigue |
| ISO 10993-1 to -22 | Biological evaluation of medical devices | Biocompatibility |
| ISO 19227 | Cleaning of orthopaedic implants | Cleaning |
| ISO 11135 | Sterilisation — EO | Sterilisation |
| ISO 11137 | Sterilisation — gamma | Sterilisation |
| ISO 11607-1/-2 | Packaging | Packaging |
| ISO 13485 | QMS for medical devices | Quality system |
| ISO 14971 | Risk management for medical devices | Risk management |
| GB/T 13810 | Wrought Ti-6Al-4V for surgical implants (China) | Material — China |
| ISO 14644 / GB 50457 | Cleanrooms and associated controlled environments | Cleanroom |