01
Do you find a burr on the sealing face?
A raised edge on an O-ring groove or a fluid path is not cosmetic. It becomes a leak path in a housing, and the whole lot goes back to rework or scrap after assembly testing.
Medical Devices
Medical Devices Rapid Prototyping
GreatLight machines, prints and forms medical device parts to ±0.005 mm. Send files and a target material; we return a quote, DFM notes and a machining plan within 12 hours.
ISO 13485:2016±0.005 mmNo MOQ100% inspectionNDA on request
±0.005 mmMachining tolerance
16Simultaneous 5-axis centers
12 hQuote and DFM analysis
15 yearsIn business since 2011
What goes wrong
Where medical device parts get into trouble
Most of these show up after assembly, not during machining. That is the expensive part.
02
Did the first articles pass while the tenth did not?
A process that drifts because the setup was not controlled will show up as a stack-up problem. One bore 0.02 mm off can close the gap on a mating shaft and stop the assembly line.
03
Are you chasing a supplier for inspection data?
Without dimensional reports from the actual run, your design history file has a hole in it. Re-qualifying later costs more than the parts did.
04
Did the material change between prototype and pilot?
A resin swap from ABS to PC, or a stainless grade change from 304 to 316L, changes stiffness, corrosion behavior and cleaning compatibility. The bench test result no longer transfers.
How we work
One process chain, from one-off prototype to pilot run
Machining, printing and forming under one roof keeps the geometry and the inspection record in the same place.
Machining
CNC for the parts that carry tolerance and load
Most medical device prototypes that need to be evaluated mechanically are machined. Housings, brackets, manifolds, instrument bodies, pull-test fixtures, valve blocks. We cut them on 5-axis centers so contoured faces and bored holes can come off one setup instead of three.
Roughing and finishing run in separate operations with a stress-relief check on thin walls. For sealing faces and bearing bores we hold ±0.005 mm and finish to Ra 0.2–0.8 μm where a gasket or a sliding fit calls for it.
- 1Materials6061-T6, 316L, 17-4PH, Ti-6Al-4V, PEEK, POM, PC, ABS
- 2Size rangeUp to 4,000 mm travel; Ø400 mm rotary table for round parts
- 3InspectionDimensional report on request, 100% check before shipment
Printing and forming
Printing and sheet metal for the early and the wide parts
When a design is still moving, printing is faster and cheaper. We use it for ergonomic housings, fluidic manifolds, fixtures and cover geometry where the fit matters more than the material. Print first, confirm the form, then cut the machined version.
Sheet metal covers the flat, thin parts: instrument panels, brackets, trays, shielding and enclosure chassis. Laser cutting, bending and hardware insertion run to the same tolerance discipline as the machining side.
- 13D printingConcept models, fit checks, fixtures, small-batch housings
- 2Sheet metalBrackets, panels, enclosures, trays; forming and hardware
- 3FinishesAnodizing, passivation, electroless nickel, bead blasting
Selection guide
Which process fits which part
Pick by function first, then by quantity.
| Part type | Process | Why |
|---|---|---|
| Housing, manifold, instrument body | 5-axis CNC | Contoured faces and bores in one setup |
| Sealing groove, bearing bore | CNC + fine finish | Ra 0.2–0.8 μm, ±0.005 mm |
| Ergonomic shell, early fit check | 3D printing | Fast geometry change, low tooling cost |
| Panel, bracket, chassis | Sheet metal | Thin flat geometry, formed edges |
| Soft jaw, nest, test fixture | CNC or printing | Quick turnaround, low volume |
| Pilot run of 500+ parts | CNC or tooling | Repeatability with inspection records |
Capabilities
What we make for medical device programs
Six service lines, one quotation path.
01
5-axis CNC machining
16 simultaneous 5-axis centers for contoured housings, angled ports and complex instrument bodies. One setup keeps position tolerance between features.
02
CNC milling and turning
27 three-axis machines, 12 four-axis mills and 16 mill-turn centers. Shafts, bushings, connectors and threaded parts turned and milled complete.
03
Rapid prototyping
Machined and printed prototypes for design verification. Quote and DFM analysis within 12 hours; production can start within 24 hours.
04
Custom 3D printing
Fit-check housings, fluidic manifolds, fixtures and covers. Useful when the design is still changing and tooling would be wasted.
05
Sheet metal fabrication
Laser cutting, bending and hardware for panels, brackets, trays and enclosure chassis. Flat parts that need to stay flat.
06
Surface finishing
Anodizing, passivation, electroless nickel, powder coating, bead blasting and laser marking with 1.5 mm minimum character height.
Scope
Range and terms at a glance
Numbers we hold to on every medical device order.
| Item | Value | Note |
|---|---|---|
| Tolerance | ±0.005 mm | ±0.0002 in where called out |
| Fine finish | Ra 0.2–0.8 μm | Sealing and bearing surfaces |
| Standard finish | Ra 1.6–3.2 μm | As-machined surfaces |
| Quantity | 1 to 10,000+ | No minimum order quantity |
| Quote | Within 12 hours | Includes free DFM analysis |
| Delivery | Parts ship in 3–5 days | After drawing release |
| Inspection | 100% before shipment | Reports on request |
| Confidentiality | NDA on request | Secure uploads |
Why GreatLight
What the shop floor actually controls
Certification gets you in the door. Process control keeps you there.
ISO 13485
Medical quality system
ISO 13485:2016 sits alongside ISO 9001:2015, IATF 16949:2016 and ISO 27001:2022. Documentation and traceability follow the medical route, not the general one.
±0.005 mm
Held on the machine
Tolerance is verified on the part, not assumed from the control. Critical features get measured in process, not only at final inspection.
127
CNC machines on site
16 five-axis, 12 four-axis, 27 three-axis and 16 mill-turn centers across 7,600 m². Capacity for one prototype or a 10,000 part run.
100%
Inspection before shipment
Raw material check, in-process monitoring, final inspection. Dimensional reports can be issued with the shipment.
12 h
Quote and DFM
Files are reviewed by an engineer, not a form. You get manufacturing notes with the price, so you know which features drive cost.
24 h
Production start
Once the drawing and material are confirmed, machining can begin within 24 hours. Historical late-delivery probability is below 2%.
7,600 m²Manufacturing space
150Technicians
3Wholly-owned plants
99.99%Qualification rate
Part families
What medical programs ask for, and what we deliver
Instrument housings
Contoured bodies with angled ports and internal pockets, machined on 5-axis.
- ±0.005 mm
- Ra 0.8–1.6 μm
- 6061-T6
Fluid path components
Manifolds and valve blocks where the bore finish controls flow and sealing.
- Ra 0.2–0.8 μm
- 316L
- 100% inspection
Fixtures and nests
Soft jaws, test fixtures and assembly nests for the line, not just the lab.
- 1 to 50 pcs
- 3–5 day ship
- POM / PEEK
Pilot runs
Repeat orders from one prototype up to 10,000+ parts with the same process.
- No MOQ
- 99.99% qualification
- ISO 13485
FAQs
Questions engineers send us
Which materials do you machine for medical device parts?
Stainless 303, 304, 316, 316L, 420, 430, 431, 440C and 17-4PH (SUS630) cover most instrument and fluid-path work. Aluminium 6061-T6 and 7075 are common for housings and fixtures.
For implants and wear parts we cut Ti-6Al-4V. Polymers include PEEK, POM, PC, ABS, PP and HDPE. If your drawing names a grade we do not list, ask before you redesign around it.
Can you hold ±0.005 mm on a prototype, not just on production?
Yes, on features we can measure. The tolerance depends on geometry, wall stiffness and material as much as on the machine.
A long thin wall in PEEK will move after clamping is released. We flag those features during DFM review and tell you what is achievable before you commit to a design.
Do you sign an NDA before I send drawings?
We can. An NDA is available on request, and uploads are handled as confidential by default.
If your internal process requires a signed agreement before files leave your network, send the document first and we will return it before you upload anything.
What is the minimum order quantity?
There is none. We run one prototype or a 10,000+ part production order.
Per-part cost drops with volume because setup is amortized, but there is no threshold you have to cross to place an order.
How fast can I get parts?
Quotation and free DFM analysis come back within 12 hours. Production can start within 24 hours of drawing and material confirmation, and parts typically ship in 3–5 days.
Complex geometry, special material stock or a required finish can extend that. We tell you which item is the constraint instead of giving a date we cannot hold.
Do you provide inspection reports?
Yes, on request. Every order gets a raw material check, in-process monitoring and a final inspection before shipment.
First article inspection reports and dimensional reports can be issued with the parts. Tell us which features are critical so the report covers them.
Can you move the part from prototype to pilot production without requalifying?
That is the point of keeping machining, printing and forming in one facility. The process that made the prototype is the process that makes the pilot run.
If the design changes between stages, we re-quote and re-inspect rather than assume the earlier data still applies.
When is 3D printing the wrong choice for a medical device part?
When the part carries load, seals a fluid path or needs a specific surface finish. Layer direction changes stiffness and creates paths along layer lines.
Use printing for form and fit, then move to machined or molded parts for anything that has to be tested to failure or cleaned repeatedly.
Send your medical device drawings
Upload files and get a quote with DFM notes within 12 hours. No minimum order quantity, 100% inspection before shipment, NDA on request.
12-hour quote100% inspectionNo MOQNDA available
