Healthcare & MedTech

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.