Certifications & Quality Standards
ISO 13485:2016
Medical devices QMS. Certified since 2009. Annual surveillance by UKAS-accredited body. Scope: design, manufacture and export of metallic orthopedic implants and instruments.
CE Mark â EU MDR
Full conformity assessment under EU MDR 2017/745 for Class IIb and III devices. SSCP published for all Class III products. NB certificate available on request.
FDA Establishment Registration
Manufacturing facility registered with FDA. Selected lines hold 510(k) clearance. Device Listing current and annually renewed.
ISO 10993 Biocompatibility
All implant materials evaluated to ISO 10993 series. Cytotoxicity, sensitisation and implantation studies documented in biological evaluation reports.
Testing Standards
| Standard | Applies To |
|---|---|
| ASTM F136 / ISO 5832-3 | Ti-6Al-4V ELI for surgical implants |
| ASTM F138 / ISO 5832-1 | 316L stainless steel for surgical implants |
| ASTM F543 | Metallic medical bone screws |
| ISO 7206-4 | Hip joint prostheses fatigue testing |
| ASTM F2083 | Knee replacement performance requirements |
| ISO 11135 / ISO 11607 | ETO sterilisation and sterile packaging |