CNC Machining for Medical Device
Precision components for medical devices and surgical instruments — machined in titanium, medical stainless and PEEK, held to ±0.002 mm on critical features on German Hermle 5-axis centers, and shipped with the inspection records that make an ISO13485 supply chain defensible.
Medical Components We Machine
Medical work is not a side line here — it runs on the same certified line, with the same engineers and the same inspection records as our aerospace and automotive programs. From a single instrument prototype to a repeat production lot, the documentation trail starts at the first sample and never breaks.
Surgical Instruments & Tool Components
Instrument handles, forceps and clamp components, retractor parts and instrument bodies in medical stainless and titanium — reuse-critical geometry held repeatably, batch to batch.
Device Enclosures & Housings
Machined housings, bezels and structural frames for imaging, monitoring and surgical equipment — cut from billet or finish-machined from our own cast blanks.
Orthopedic & Trauma Components
Bone screw, plate and instrument components machined in implant-grade titanium and stainless to print — every lot backed by material certificates and batch traceability.
Fluid Handling & Analytical Parts
Pump bodies, manifolds, valve components and flow-path parts for IVD analyzers and laboratory fluidics, machined burr-free with the flow geometry your assay depends on.
Shafts, Pins & Precision Fittings
Instrument shafts, pivot pins, couplings and fittings where fit, finish and repeatability decide how the instrument performs in the surgeon's hand.
Diagnostic & Lab Equipment Parts
Optical housings, mounts, brackets and precision hardware for diagnostic instruments and laboratory automation systems.
Medical Machining Capabilities
Named machines, verified tolerances, documented inspection. This is the equipment behind every medical component we machine — the same fleet our 5-axis CNC machining service runs on.
| Capability | Equipment & Specification |
|---|---|
| 5-Axis Machining Centers | 9 units — German Hermle C22U / C42U / C42UMT / C52UMT / C62UMT (×8) + Swiss Mikron (+GF+) MILL E 500U (×1) |
| Turn-Mill Centers | 5 Hermle UMT centers — milling + turning in a single setup |
| 3/4-Axis Machining Centers | Japan FANUC ×16 · Taiwan Hartford ×23 · Korea Doosan ×5 · Kejie ×5 |
| CNC Lathes | Japan OKUMA / Takisawa ×20 |
| Critical-Feature Tolerance | ±0.002 mm on 5-axis critical features (machine rated) |
| Quoted Tolerance | Designed feature-by-feature — ±0.002 mm where the part demands it, cost-optimized everywhere else |
| Inspection | German Zeiss CORTORA CMM 12/18/8 RDS (0.001 mm) ×2 · Hexagon absolute measuring arm (0.006 mm) · VMS-3020G vision system ×2 · full gage suite |
| Outgoing Inspection | 100% inspection on every shipment — inspection reports, FAI and CoC available; PPAP on request |
| On-Time Delivery | 98% |
| Minimum Order | No MOQ — from a single prototype piece |
Tolerance is only half of a medical qualification
±0.002 mm means nothing to a device customer without the record behind it. Every critical feature is verified on a Zeiss CORTORA CMM with 0.001 mm resolution, 100% of shipments pass final inspection, and material lots stay linked to the finished part. That documented tolerance-to-verification loop — ready to hand over, part by part, in your supplier file — is what medical buyers are really purchasing.
Materials for Medical Devices
The alloys and polymers medical device programs specify — implant-grade titanium, medical stainless and high-performance plastics, sourced against the grades on your drawing.
Ti-6Al-4V · Gr 23 ELI · CP Gr 2
- Ti-6Al-4V (Gr 5)
- Ti-6Al-4V ELI (Gr 23)
- CP Ti (Gr 2)
Implant-grade and commercial titanium for instrument and orthopedic component work.
316L / 316LVM · 17-4PH
- 316L / 316LVM
- 17-4PH
- 303 / 304
Corrosion-resistant grades for instruments, fittings and reusable device parts.
PEEK · PEI · PSU · PTFE
- PEEK
- PEI (ULTEM)
- PSU
- PTFE · POM
Machined polymers where metal is ruled out — insulators, bushings and fluid-path parts.
6061-T6 · 7075-T6
- 6061-T6
- 7075-T6
- 6063
Device housings, frames and hardware where weight and cost drive the choice.
C36000 Brass · C110 Copper
- C36000 Brass
- C110 Copper
Connectors, terminals and electrical hardware for device electronics.
Surface Finishing for Medical Components
ISO13485 & Quality Control
Certifications you can ask to see, and a measurement chain that documents every number we quote — the evidence a medical device customer’s audit needs.
AS9100D
Aerospace & Defense quality management — independently audited, current, certificate available on request.
IATF16949
Automotive quality management — same rigor applied to high-volume production programs.
ISO9001
Quality management foundation across all three Hanstar plants.
ISO13485
Medical device quality management — relevant when aerospace meets sterile and implantable-grade controls.
Why Hanstar for Medical
Founded 1998. ISO13485 certified. Three plants. One quality system — what makes Hanstar the custom manufacturer behind your device component program.
Medical Device Machining — Frequently Asked Questions
Straight answers to the questions buyers ask before sending a drawing.
Are you ISO 13485 certified for medical device machining?
Yes. We hold ISO 13485 certification, alongside AS9100D, ISO 9001 and IATF 16949. Certificate details and customer-specific quality documentation are available upon request.
What materials do you machine for medical devices?
We machine titanium, stainless steel, aluminum, engineering plastics and copper alloys, including Ti-6Al-4V, 316LVM, PEEK and PEI (ULTEM). Material certificates are available according to project requirements.
What tolerances can you hold on medical components?
We achieve tolerances down to ±0.002 mm on selected critical features under suitable machining and inspection conditions. Actual tolerances are defined by your drawing and verified using ZEISS CMM inspection equipment.
Do you provide material certificates and lot traceability?
Yes. We maintain material identification and lot traceability throughout production, linking incoming materials to manufacturing and inspection records. Traceability documentation and material certificates are available according to project requirements.
Can you machine implant-grade titanium and PEEK?
Yes. We machine specified titanium grades, including Ti-6Al-4V ELI (Grade 23), as well as PEEK and other engineering polymers. Please share your drawing and material specifications so we can confirm manufacturing and documentation requirements.
What documentation do you provide for medical device parts?
Documentation can include dimensional inspection reports, Certificates of Conformance (CoC) and material certificates. FAI reports and inspection data packages can also be prepared according to your project requirements.
Is there a minimum order quantity for medical device components?
No minimum order quantity. We support projects ranging from single prototypes and low-volume validation batches to repeat production orders.
Do you sign NDAs before I send drawings?
Yes. We can review and sign customer-provided NDAs or use an agreed confidentiality agreement before receiving confidential drawings. Customer technical information is not published without written authorization.
