Medical devices.
Implants. Tools.
FDA-grade.
Medical fabrication services. Implants, surgical instruments, diagnostic equipment, dental devices. ISO 13485-compatible documentation, USP Class VI materials.
Key principles.
Ti-6Al-4V ELI
Spinal, orthopedic, dental implants. Titanium ELI grade.
316LVM
Sterilizable surgical instruments.
Various
Diagnostic equipment components.
Ti / zirconia
Dental instruments, prosthetic components.
316L EP
Bioprocess equipment.
ISO 7/8
Cleanroom assembly per spec.
FAQ
ISO 13485 compatible documentation?
Yes — supporting customer ISO 13485 QMS. Material certs, processing records, inspection.
USP Class VI materials?
PEEK-OPTIMA, USP VI silicone, FDA-listed plastics. For implant or drug-contact applications.
Sterilization compatibility?
Steam autoclave 121°C, gamma radiation, EtO. Material/design verified per method.
Cleanroom assembly?
ISO 7/8 cleanroom available. Particle-controlled. Sterile-ready packaging.
Patient-specific?
From CT/MRI imaging. CAD model generated. Manufactured to anatomy. Verified vs fit.
Documentation retention?
Permanent implants 25+ years. Surgical instruments 7+ years. Per medical industry.
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