ISO 13485 certified production of biocompatible components, surgical instruments, and implantable devices with full regulatory traceability and cleanroom assembly capabilities.
MetalCore's medical division specializes in the design, precision manufacturing, and clean assembly of regulated medical devices. From Class I to Class III components, we partner with OEMs, contract manufacturers, and startups to deliver auditable, compliant, and high-reliability parts for surgical, diagnostic, and therapeutic applications.
5-axis machining and Swiss-style turning for complex implant geometries, stents, and surgical tooling with tight tolerances.
ISO Class 7 & 8 cleanroom environments for sterile assembly, kitting, and sub-assembly of sensitive medical devices.
High-cavity tooling for biocompatible polymers, UHMWPE, PEEK, and silicone with consistent part quality.
Validated EO, Gamma, and eBeam sterilization compatibility. ISO 15883 compliant cleaning processes.
Direct part marking, laser etching, and UDI compliance. Full lot tracking and electronic batch records.
ISO 11607 compliant sterile barrier systems, peel pouches, and tray packaging ready for global distribution.
Full quality management system tailored to medical device lifecycle and regulatory requirements.
Design controls, CAPA, deviation management, and full audit readiness for US market submissions.
Technical file documentation, biocompatibility testing coordination, and EU regulatory pathway assistance.
Electronic DHRs, material certs (COC/COA), process validation reports, and full genealogy tracking.
| Material | Grade / Standard | Applications | Processing |
|---|---|---|---|
| Titanium | Ti-6Al-4V ELI, ASTM F136 | Orthopedic implants, spinal cages, surgical tools | 5-Axis CNC, EBM/SLM, Anodizing |
| Stainless Steel | 316L, 17-4PH, 420 | Surgical instruments, endoscopic components | Swiss turning, EDM, Passivation |
| Cobalt-Chrome | CoCrMo ASTM F75/F1537 | Joint replacements, dental implants | High-speed CNC, Hard turning |
| PEEK | ULTEM™, VICTREX™ | Spinal cages, surgical handles, housings | Injection molding, Machining |
| UHMWPE | ASTM F1815 / F2684 | Acet liners, articulating surfaces | Precision machining, Compression molding |
CMM, optical scanning, and profile projectors for GD&T verification against blueprints and 3D models.
Ra 0.4μm finishes, electropolishing, and passivation validated for biocompatibility and corrosion resistance.
FAI reports, material certs, process validations, and sterilization compatibility data delivered with every lot.
Data-driven quality systems with automated SPC, root cause analysis, and regulatory-compliant corrective actions.
High-precision bone screws, plates, spinal cages, and joint surfaces with validated biocompatibility.
Handles, shafts, grips, and specialized tooling for laparoscopic and open surgical procedures.
Precision housings, sensor mounts, and optical components for MRI, CT, and ultrasound systems.
Share your drawings, material specs, and regulatory requirements. Our medical engineering team will respond with a detailed capability review and timeline within 24 hours.