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Healthcare & MedTech Components
Precision CNC machining, 3D printing, and injection molding with biocompatible materials, regulatory-aligned processes, and full traceability
Precision-engineered components for life-critical healthcare applications
Forceps, clamps, retractors, scalpel handles, laparoscopic tools, micro-surgical instruments
Hip stems, knee components, spinal cages, bone plates, screws, trauma fixation devices
Imaging device components, endoscope parts, biopsy tools, sensor housings, fluid handling systems
Healthcare components demand absolute precision - lives depend on it
Specialized expertise in healthcare and medtech component manufacturing with regulatory-aligned processes
Manufacturing processes designed to support FDA regulatory requirements and ISO 13485 quality management standards through our partner network, ensuring consistent, traceable production for healthcare and medtech companies.
Specialized experience with medical-grade titanium, stainless steel, PEEK, and other biocompatible materials certified for implantable and surgical applications.
Full material certificates, dimensional inspection reports, biocompatibility documentation, and lot traceability for regulatory compliance and audit readiness.
Sub-micron tolerances and validated process capability for life-critical healthcare applications requiring absolute precision and reliability.
Surface treatments and finishes compatible with autoclave, EtO, gamma radiation, and other medical sterilization methods without degradation.
Controlled manufacturing environments meeting ISO Class 7 and Class 8 cleanroom standards for contamination-sensitive medical components.
Precision-engineered components for healthcare and medical technology applications
High-precision surgical instruments and guidance components
Custom enclosures for diagnostic devices and wearable medical technology
Precision components for pharmaceutical delivery systems including pumps and valves
Custom-machined components for orthotic and prosthetic devices
Specialized components for endoscopic and minimally invasive surgical devices
Medical-grade materials with full certification and traceability
Titanium Alloys: Medical-grade implantable materials - ASTM F136 (Ti-6Al-4V ELI), ASTM F67 (CP Grade 2, Grade 4), ASTM F1472 (Ti-6Al-4V Surgical Implant), ASTM F1713 (Ti-13Nb-13Zr), ASTM F2066 (Ti-15Mo), AMS 4928 (Ti-6Al-4V Sheet)
Stainless Steel: Surgical and implant grades - ASTM F138 (316L Surgical Implant), ASTM F139 (316LVM), ASTM F55 (S31254), ASTM F899 (Stainless Steel Wire), 17-4PH (ASTM A564), 440C (High hardness surgical)
PEEK Polymers: High-performance medical plastics - PEEK 450G (Natural, Medical Grade), PEEK-OPTIMA (Implant Grade), Carbon-Reinforced PEEK, Radiopaque PEEK, TECAPEEK MT (Biocompatible)
Cobalt-Chrome Alloys: Orthopedic implant materials - ASTM F75 (CoCrMo Cast), ASTM F90 (CoCrMo Wrought), ASTM F562 (MP35N), ASTM F1537 (CoCrNiCrMo)
Biocompatible Polymers: Healthcare and medtech plastics - PPSU (Polyphenylsulfone), ULTEM 1010 (PEI Medical), Polycarbonate (Medical Grade), Acetal Copolymer (Delrin Medical), UHMWPE (Ultra-High Molecular Weight PE)
Precious Metals: Specialty medical applications - Platinum (ASTM B818), Platinum-Iridium Alloys, Gold (Medical Grade), Palladium Alloys, Nitinol (NiTi - Shape Memory, ASTM F2063)
Comprehensive documentation for regulatory compliance and audit readiness
Material certificates with biocompatibility documentation (ISO 10993)
Dimensional inspection reports with GD&T verification
Certificate of Conformance referencing purchase orders
Lot traceability from raw material to finished component
Surface finish verification (Ra values documented)
Cleaning and passivation certificates
First Article Inspection (FAI) reports when required
Our manufacturing processes are designed to support healthcare and medtech regulatory requirements through our partner network. We work closely with ISO 13485-certified facilities and maintain processes aligned with FDA quality system regulations. This includes comprehensive documentation, material traceability, process controls, and quality management systems that help our clients meet their compliance obligations.
We specialize in medical-grade materials including Ti-6Al-4V ELI (ASTM F136), 316L/316LVM surgical stainless steel (ASTM F138/F139), cobalt-chrome alloys (ASTM F75), PEEK-OPTIMA implant-grade polymers, and other biocompatible materials. All materials come with full mill certificates and biocompatibility documentation.
Yes. We provide complete material traceability including mill certificates, heat lot numbers, biocompatibility test reports (ISO 10993 where applicable), chemical composition analysis, and mechanical properties certification. Every component is traceable from raw material source through final inspection.
We routinely achieve tolerances of ±0.0005″ (±0.0127mm) and can reach ±0.0002″ (±0.005mm) for critical features. Our 5-axis CNC centers and precision inspection equipment (CMM, optical comparators) ensure repeatable accuracy for complex medical geometries and tight GD&T requirements.
Yes. We provide electropolishing, passivation (citric or nitric acid), anodizing (Type II and Type III), and precision grinding to achieve surfaces compatible with autoclave, EtO gas, gamma radiation, and electron beam sterilization. Surface roughness is documented and verified to meet your specifications.
Prototype and first article runs: 2-3 weeks with full FAI documentation. Low-volume production (10-100 parts): 3-4 weeks. Production runs with established processes: 2-3 weeks depending on complexity. Rush programs available for urgent healthcare and medtech development projects.
Yes. We have experience manufacturing precision components used in Class II and Class III medical devices including implantables, surgical instruments, and life-sustaining equipment. We understand the heightened documentation, traceability, and quality requirements for components used in higher-risk applications.
We have access to controlled manufacturing environments meeting ISO Class 7 and Class 8 cleanroom standards for contamination-sensitive medical components. Particulate control, environmental monitoring, and cleanroom protocols can be implemented based on your device requirements.