Medical Industry Solutions

Surgical instruments, implants and diagnostic devices combine tight mechanical specs with a regulatory environment where every decision leaves a paper trail — and we are comfortable in both, with ISO 13485 audit readiness.

Applications

What we make for medical

Surgical instrument shaft and handle in stainless

Surgical & Orthopedic Instruments

Surgical instrument shafts, jaws, handles and driver tips for orthopedic (hip, knee, spine), MIS (laparoscopic, robotic-assisted) and ENT procedures. Machined in 17-4 PH (precipitation-hardened), 440C and 465 stainless with articulating surfaces finished to Ra 0.2 µm and critical dimensions held to ±0.005 mm. Every lot ships with material traceability (heat/lot number), passivation certs (ASTM A967) and dimensional inspection against your print. Common features: serrated jaws with consistent tooth height (±0.01 mm), ratchet mechanisms with calibrated click torque, and quick-release couplings for modular instrument systems. We support your FDA 510(k) and CE Mark documentation requirements with DHF-aligned process records.

Diagnostic device housing and fluidic manifold

Diagnostic & Imaging Hardware

Fluidic manifolds, lens mounts, positioning stages and housing panels for CT, MRI, ultrasound and point-of-care diagnostic equipment. We work to your DHF and DMR documentation requirements with photographs, process notes and customer-defined FIFO inventory holds. 316L stainless and anodized 6061-T6 are our most common materials for this segment. Common features: fluidic channels with ±0.025 mm on cross-section, lens barrels held to ±0.005 mm on optical axis, and multi-axis positioning stages with ±0.01 mm repeatability. We can also machine RF-shielded enclosures (Cu, Al) with EMI gasket channels machined to ±0.025 mm for MRI and CT applications.

Surgical robot instrument shaft and wrist mechanism

Surgical Robotics

Instrument shafts, wrist mechanism housings, trocar port assemblies and sterile-barrier interface components for surgical robot platforms (da Vinci, Hugo, Ottava, Mako). Sub-thousandth tolerances on shaft diameters and pivot bores — our standard flight-critical tolerance for surgical robotics is ±0.0127 mm (0.0005 in). All stainless components are passivated (ASTM A967) and electropolished for autoclave and EtO sterilization compatibility. We machine in 17-4 PH, 316LVM and Ti-6Al-4V ELI, and we maintain separate tooling and fixtures for implant/robotics work to eliminate cross-contamination risk. Every lot ships with material certs, dimensional report and, where specified, electropolish certification (ASTM B912) and surface-passivation test (per ASTM A967).

Dental handpiece components and precision gear mechanism

Dental Equipment

Handpiece bodies, contra-angle gear trains, bur chuck mechanisms and implant surgical guides. Typical materials: 316L stainless for body and gear components, Ti-6Al-4V ELI for implant surgical guides, and Peek for radiolucent components. Tolerances from ±0.005 mm on gear teeth and bearing surfaces to ±0.02 mm on body housings. We work with dental OEMs to achieve surface finishes down to Ra 0.2 µm on gear contact surfaces, and we can provide full material certs and surface-finish documentation for FDA 510(k) submissions. Common features: precision-machined splines (6, 8, 12 tooth) to AGMA standards, Luer-lock fittings, and ISO 7785-compliant bur-chuck interface dimensions.

Prosthetic knee implant and orthopedic components

Prosthetic & Orthopedic Implants

Knee and hip femoral components, tibial trays, spinal cage features and bone screw driver interfaces machined to implant-grade tolerances. Materials: Ti-6Al-4V ELI (ASTM F136), CoCrMo (ASTM F75 or F799), and 316LVM (ASTM F138). Surface finishes on bearing surfaces reach Ra 0.05 µm (super-polished) or Ra 0.2 µm (standard). Critical dimensions hold ±0.005 mm; porous-coating pore geometry is CNC-machined to ±0.025 mm. All material is sourced from ISO 13485-certified vendors with FDA Master File support. We coordinate with your FDA 510(k) or PMA submission team on Device Master Record (DMR) documentation, Device History Record (DHR) travelers, and biocompatibility testing (ISO 10993) coordination. Our facility maintains dedicated implant-grade tooling and floor segregation.

Medical monitoring equipment precision components

Life-Critical Monitoring Equipment

Precision-machined enclosures, sensor manifolds and patient-interface components for patient monitors, infusion pumps and respiratory devices. These components operate in clinical environments and must meet IEC 60601-1 electrical safety and EMC standards. We machine in 316L stainless, anodized 6061-T6 aluminum and medical-grade plastics (PEEK, PSU) — holding ±0.01 mm on enclosure-datum features and ±0.025 mm on general features. Common requirements: EMI gasket channels machined to ±0.025 mm, fluidic manifolds pressure-tested to 1.5× operating pressure, and biocompatibility documentation per ISO 10993 for patient-contact surfaces. We provide dielectric withstand test data, IP-rating documentation and EMC-grounding surface preparation as required by your electrical safety team.

How we work

Materials, tolerances, collaboration

Medical devices combine tight mechanical specs with a regulatory environment where every decision leaves a paper trail. We work with surgical-instrument makers, implant specialists and diagnostic OEMs — and we are used to documenting the chain from bar stock to the sterilized package that arrives at your warehouse. Our quality system supports ISO 13485 audit requirements, and we maintain a 10-year document retention archive per project.

Materials and tolerances

For implant-adjacent work we work in 316LVM stainless, Ti-6Al-4V ELI, and CoCrMo. Instruments are typically 17-4 PH, 440C or 465 stainless. Surface finishes reach Ra 0.2 µm on articulating surfaces. Critical dimensions hold ±0.005 mm; non-critical features release at ±0.025 mm. We maintain separate tooling and fixtures for implant-grade work to prevent cross-contamination between material grades.

Quality system

Each lot ships with material traceability (to raw-material heat/lot number), dimensional inspection against your print, and passivation or electropolishing documentation where applicable. We can hold your part in our inventory under a customer-defined FIFO policy, and support your DHF and DMR review with photographs, process notes and FAI reports. Our ISO 9001 quality system is expandable to ISO 13485 audit requirements with advance notice.

Sterilization compatibility

Parts are designed and finished to survive the sterilization method your device uses — autoclave (134 °C steam), EtO gas, hydrogen peroxide plasma, or gamma irradiation. Material selection, surface treatment and packaging are all specified against your sterilization method from the start, so there are no surprises at biocompatibility testing. We can provide sterilization compatibility studies (per ISO 17664) on your behalf through our certified testing partners.

Custom Machined

Custom Machined Your Medical Components

With an extensive history in prototyping medical components, we bring a wealth of knowledge and expertise to every project. Send the CAD and the target outcome — engineering will reply with a focused quote within one business day, routed to the cell most familiar with this vertical.

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