Quality System Certifications
The QMS that supports every product.
Active
GMP
Production of Class III medical devices. Audited by China NMPA.
Active
ISO 13485:2016
Quality management systems for medical devices. International QMS standard.
Active
ISO 14971
Application of risk management to medical devices.
Regulatory Approvals
By jurisdiction.
| Jurisdiction | Class | Pathway | Status | Authority |
|---|---|---|---|---|
| China | Class III | NMPA registration (国械注准) | Granted | NMPA / CMDE |
| EU | Class III, Rule 8 (MDR 2017/745) | Conformity assessment via Notified Body | In progress | TÜV SÜD / DEKRA (target) |
| United States | Class II (likely), 21 CFR 882.5320 (GWO) or similar | 510(k) clearance | In scoping | FDA CDRH |
| UK | Class III (UKCA) | UK Approved Body | In scoping | UL / BSI (target) |
| Australia | Class III (ARTG) | TGA conformity assessment | In scoping | TGA |
| Brazil | Class III | ANVISA registration | In scoping | ANVISA |
| Canada | Class III | Health Canada MDL | In scoping | Health Canada |
| Japan | Class III | PMDA pre-market approval | In scoping | PMDA |
| MDSAP | Audit programme | Single audit covering US/CA/AU/JP/BR | In scoping | MDSAP AO |
Standards Compliance
Material, manufacturing, mechanical, biological.
| Standard | Title | Scope |
|---|---|---|
| ASTM F136 | Wrought Ti-6Al-4V ELI for surgical implants | Material — US / global |
| ASTM F382 | Metallic bone plates — mechanical test methods | Mechanical — US |
| ASTM F2026 | PEEK polymers for surgical implant applications | Reference (PEEK) |
| ASTM F3301 | Additive manufacturing of metallic medical implants | AM — US / global |
| ASTM F3434 | Guide for AM of metallic medical implants | AM characterisation |
| ASTM F86 | Surface passivation of metallic surgical implants | Surface — US / global |
| ISO 5832-3 | Titanium alloys for surgical implants — Ti-6Al-4V | Material — EU / global |
| ISO 9585 | Bending & torsion fatigue of bone plates | Fatigue — EU / global |
| ISO 10993-1 to -22 | Biological evaluation of medical devices | Biological — EU / global |
| ISO 19227 | Cleaning of orthopaedic implants | Cleaning — EU / global |
| ISO 11137 | Sterilisation — gamma | Sterilisation — EU / global |
| ISO 11135 | Sterilisation — EO | Sterilisation — EU / global |
| ISO 11607-1/-2 | Packaging | Packaging — EU / global |
| ISO 13485 | QMS for medical devices | QMS — EU / global |
| ISO 14971 | Risk management for medical devices | Risk — EU / global |
| ISO 10360 | CMM inspection | Dimensional |
| GB/T 13810 | Wrought Ti-6Al-4V for surgical implants (China) | Material — China |
| ISO 14644 / GB 50457 | Cleanrooms and associated controlled environments | Cleanroom |