Shenzhen Center for Advanced Additive Manufacturing & Biomanufacturing.
Our 800 m² operational smart factory is certified for Class III device production. The first phase of a planned 5,000 m² expansion will scale capacity to meet global demand.
800 m² of certified Class III production.
Located in the Quanzhi Technology Innovation Park, Bao'an District, Shenzhen, our operational smart factory features a fully validated GMP production line for personalised Class III implants. Every step — from powder handling to sterile packaging — is engineered for traceability and reproducibility.
- Class III cleanroom compliant with ISO 14644 and GB 50457
- Electron Beam Melting cells dedicated to titanium implant production
- 100% CMM inspection with traceability to the patient's CT dataset
- ISO 11607-compliant double-pouch packaging in ISO Class 7 environment
- EO sterilisation validated to ISO 11135
5,000 m² Phase II. Built for global demand.
The Phase II facility is engineered to scale our production capacity by 5–10x. It will integrate additive manufacturing, post-processing, and biomanufacturing under a single digital twin.
Capacity expansion
5,000 m² GMP-standard production halls. Doubles EBM capacity. Adds automated post-processing cells.
R&D scale-up
New laboratories for ME-Regen® protein engineering and Cell home® tissue engineering. Pilot lines for both.
Commercial & clinical
Surgeon training centre, KOL engagement space, regulatory affairs office, and global customer support.
The most advanced additive manufacturing stack in CMF.
| Workstation | Capability | Specification |
|---|---|---|
| EBM cells | Electron Beam Melting of Ti-6Al-4V ELI | Vacuum < 1×10⁻³ mbar · 60 kV / 3–30 mA · 700 °C pre-heat · 50–100 µm layer |
| Stress relief / HIP | Post-build thermal treatment | 730 °C / 2 h vacuum; optional 900–950 °C / 100 MPa / 4 h HIP |
| Wire EDM | Part separation from build plate | ±0.05 mm positional accuracy |
| CNC trimming | Drill / tap interfaces and rim finishing | 5-axis; in-house fixtures for patient-specific parts |
| CMM | 100% dimensional inspection | ISO 10360; full STL comparison; automated reporting |
| In-house CT | Finished part vs. design STL conformity | Non-destructive; voxel ≤ 50 µm |
| Passivation | Nitric acid surface treatment | ASTM F86 |
| Cleanroom packaging | Double-pouch + Tyvek in ISO Class 7 | ISO 11607-1/-2 |
| EO sterilisation | Validated cycle for titanium implants | ISO 11135 |
Tour the facility
Qualified clinical and commercial partners are invited to visit our Shenzhen facility. We host KOL and distributor tours quarterly.