Precision Manufacturing
for Medical Devices
CNC machining for surgical instruments, implant components, and medical enclosures. FDA-compliant with full material traceability.
Medical Production Capability
Controlled processes developed around medical-device requirements, from micro-machining to full regulatory compliance.
±0.01mm tolerances for miniature medical components. Swiss-type turning, micro-milling, and precision grinding for complex geometries.
Certified medical-grade titanium, PEEK, cobalt-chrome, and stainless steel. Full material certification and traceability documentation.
ISO 13485 certified QMS with first article inspection, in-process controls, and final validation. CMM inspection with full reports.
Passivation, electropolishing, anodizing, and biocompatible coatings. Sterile-compatible surface finishes for surgical applications.
Controlled environment manufacturing for contamination-sensitive medical devices. Cleanroom assembly and packaging options available.
A Controlled Path from Design to Delivery
A structured medical manufacturing workflow with full documentation at every stage.
Design Review & DFM
For medical-device programs, engineering team reviews CAD files for medical device manufacturability. Material selection guidance, tolerance analysis, and regulatory requirement assessment.
Material Procurement
Within a controlled medical manufacturing workflow, certified medical-grade materials sourced with full mill certifications. Material test reports (MTR) and biocompatibility documentation for regulatory submissions.
Precision Manufacturing
Where documentation and traceability are essential, CNC machining with in-process inspection at critical dimensions. Temperature-controlled environment, documented tool changes, and process parameter monitoring.
Quality Validation
Validation combines CMM dimensional checks, surface-finish measurement, and visual inspection. Records include First Article Inspection (FAI) reports, CoCs, and complete traceability documentation.
Delivery & Documentation
For medical-device programs, clean packaging with complete documentation package. Device Master Record (DMR) excerpts, material certifications, and inspection reports for regulatory files.
Medical Device Applications
Specialized manufacturing for diverse medical applications, each satisfying specific regulatory requirements.
Precision Surgical Tools
Within a controlled medical manufacturing workflow, handles, cutting instruments, clamping devices, and surgical shafts. Sterile-compatible finishes, biocompatible materials, and reusable instrument specifications.
Implant Components
Where documentation and traceability are essential, orthopedic, spinal, and dental implants with biocompatible certification.
Diagnostic Housings
For medical-device programs, analytical equipment enclosures with precision optical alignment features.
Medical Enclosures
Within a controlled medical manufacturing workflow, iP-rated housings with antimicrobial surfaces and cleanroom assembly.
Imaging Components
Where documentation and traceability are essential, mRI-compatible, X-ray, and ultrasound probe components.
Mobility Equipment
For medical-device programs, wheelchair frames, motor housings, and structural components.
Materials for Medical Components
Certified biocompatible materials with end-to-end traceability. Every material lot is documented with mill certifications, biocompatibility data, and material test reports for regulatory submissions.
Titanium Ti-6Al-4V
ASTM F136PEEK-OPTIMA
ISO 10993Measured Quality Performance
ISO 13485 certified quality management system with continuous improvement.
Project Documentation Package
Every medical device project includes complete documentation for regulatory submissions, quality records, and traceability requirements.
Material Certifications (MTR)
Where documentation and traceability are essential, mill test reports with heat numbers, chemical composition, and mechanical properties.
First Article Inspection (FAI)
For medical-device programs, complete dimensional report per AS9102 requirements with balloon drawings.
Certificate of Conformance (CoC)
Verification that parts satisfy all specifications and regulatory requirements.
Device Master Record (DMR)
Within a controlled medical manufacturing workflow, excerpts for regulatory files including process parameters and specifications.
Plan Your Medical Device Project
Where documentation and traceability are essential, partner with an ISO 13485 certified manufacturer. Upload CAD files for medical-specific DFM review and regulatory compliance assessment.