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Medical device stamping

Precision Stamping Medical Devices

We run progressive and compound dies for medical device components in stainless, titanium and copper alloys. ISO 13485:2016 processes, ±0.005 mm tolerance, and full traceability from raw material to final inspection.

ISO 13485:2016±0.005 mmNo minimum orderFull traceability15 years
medical-devices-rapid-prototyping
15 yearsMetal forming since 2011
±0.005 mmAchievable stamping tolerance
99.99%Qualification rate
100%Inspection before shipment
Where stamping projects fail

Do these problems look familiar?

Most medical stamping problems are decided long before the press runs.

01

Burrs and slivers on the cut edge

A sharp edge on a lancet or a retainer can injure the operator or a patient. If the die is not maintained on a schedule, edge wear shows up as a burr you only catch under magnification. We track die life and re-sharpen before it reaches that point.

02

Flatness drift after forming and heat treat

A sensor bracket that leaves the press flat can bow after stress relief or passivation. If that drift is not measured on a granite plate, it reaches assembly and the stack no longer closes. Flatness must be specified, measured and inspected, not assumed.

03

Material certificates that cannot be traced

An auditor asks for the melt lot behind a stainless clip and the supplier answers with a general mill certificate. Without heat-number traceability on the route card, the whole lot is suspect. Retesting or scrapping a finished batch costs far more than the paperwork.

04

A prototype that cannot be scaled

Laser-cut samples pass bench testing, then the production die produces a different edge condition and a different burr height. The design was never checked against real die constraints. Fix the process window before tooling is cut, not after.

How we build the part

Stamping process control, not just a press

Two capabilities decide whether the run holds tolerance: tool design and in-process measurement.

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Tooling

Die design that matches the medical part

Progressive dies suit high-volume parts with several forming stations: a clip, a shield, a contact spring. Compound dies suit flatter parts where burr height and flatness matter more than speed. We pick the die architecture after looking at the drawing, the material and the annual quantity.

Strip layout is where cost is set. We check strip width, bridge width, pilot holes and scrap ratio before quoting. A layout that wastes 30 % of the strip is a layout that charges you for metal you never use.

  • 1
    Stainless 301, 304, 316L, 17-4PHSpring temper and corrosion-resistant grades for clips, retainers and housings.
  • 2
    Titanium and copper alloysTA1, TA2, TC4, beryllium copper and C110 for contacts and electrodes.
  • 3
    Burr controlEdge condition specified as a height limit, then checked with a profile projector.

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CNC Lathe Technical Specifications Terminology
Secondary operations

From stamped blank to clean, plated, inspected part

A stamped blank rarely ships as-is. Deburring, tumbling, passivation, electropolishing, plating, laser marking and assembly are performed under the same quality system, so the part does not travel between vendors and lose its traceability.

For implant-adjacent or reusable surgical parts, passivation and cleaning matter as much as geometry. We work to the surface condition on the drawing and document the sequence on the route card.

  • 1
    Deburring and tumblingFor edge breaks that cannot be reached in the die.
  • 2
    Passivation and electropolishingFor stainless parts where free iron and surface oxide are a risk.
  • 3
    Laser markingMinimum character height 1.5 mm, with a readable, permanent mark.

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Process choice

Which process fits the part

Use this to decide whether a part belongs on a die, a laser or a mill.

FeatureStampingLaser + formingCNC machining
Annual volume5,000+ pieces1 to 5,000 pieces1 to 2,000 pieces
Tooling costDie requiredNo dieNo die
Edge qualityControlled burr heightHeat-affected edgeMachined edge
Best forClips, springs, shieldsFlat brackets, coversBodies with 3D features
Change costHigher after toolingLow, edit the programLow, edit the program
What we run

Services behind a medical stamping program

One supplier for the die, the part, the finish and the inspection report.

01

Precision stamping

Progressive and compound dies for stainless, titanium, copper and aluminum strip. Burr height controlled to the drawing.

02

Sheet metal fabrication

Laser cutting, bending and welding for enclosures, chassis and brackets that sit beside the stamped parts.

03

Rapid prototyping

Laser-cut and machined samples before the die is cut, so the design is proven at bench scale.

04

CNC machining

127 high-precision machines for inserts, fixtures and small runs that never justify a die.

05

Surface finishing

Anodizing, plating, passivation, bead blasting and laser marking, all documented on the route card.

06

Assembly and inspection

Sub-assembly, functional checks and dimensional reports before the box is sealed.

Scope and limits

What the quote covers

Numbers below are the ones we work to, not marketing ranges.

ItemCapabilityNotes
Tolerance±0.005 mmOn critical stamped features
Surface finishRa 0.8–1.6 μmFine finishing to Ra 0.2–0.8 μm
Maximum part size4,000 mmLarger sheet assemblies on request
Order quantity1 to 10,000+No minimum order quantity
Material traceabilityHeat number on route cardMill certificates on request
Inspection100% before shipmentReports on request
Why GreatLight

What we bring to a regulated program

Six things a procurement engineer can actually verify.

ISO 13485

Medical quality system

ISO 13485:2016 sits alongside ISO 9001:2015, IATF 16949:2016 and ISO 27001:2022. Device makers can audit against a system they already recognize.

±0.005 mm

Tolerance we hold

Critical stamped features are held to ±0.005 mm and verified on the inspection bench, not inferred from the die drawing.

15 years

Forming experience

Metal forming since 2011, across stainless, titanium, copper and aluminum strip, in three wholly-owned plants.

12 hours

Quote and DFM

A quotation and a free DFM analysis come back within 12 hours. Production can start within 24 hours of approval.

3–5 days

Shipping window

Parts ship in 3–5 days on standard programs. Historical late-delivery probability sits below 2%.

NDA

Confidential handling

Uploads are secure, drawings stay confidential, and a non-disclosure agreement is available before you send the first file.

7,600 m²Manufacturing space
150Technicians on staff
3Plants, Dongguan and Singapore
99.99%Qualification rate
Industry requirements

What medical programs ask for, and what we deliver

GreatLight Metal new factory building

Surgical instruments

Stainless blanks and spring elements that must survive repeated sterilization without edge damage.

  • ±0.005 mm
  • ISO 13485
  • Passivation
Leader in Cnc Machining Service China

Diagnostic and lab equipment

Shields, contacts and retainers where flatness and burr height drive the assembly stack.

  • Flatness checked
  • Burr height limited
  • 100% inspection
oplus_262178

Wearable and monitoring devices

Small stamped housings and clips in titanium and aluminum where weight and fit matter.

  • Titanium
  • 3–5 day ship
  • No MOQ
6011

Implant-adjacent hardware

Traceable stainless and titanium parts with heat-number records and inspection reports.

  • Heat-number traceability
  • Reports on request
  • ISO 9001
FAQs

Questions engineers ask before tooling

When does a medical part justify a stamping die instead of laser cutting?

Volume decides it. Below roughly 5,000 pieces a year, laser cutting plus forming is usually cheaper because there is no die to amortize.

Above that, progressive stamping wins on piece price, repeatability and edge quality. We will tell you when the crossover sits for your part instead of pushing tooling you do not need.

What burr height can you hold on a stainless edge?

It depends on material thickness and edge geometry. For thin stainless strip, burr height on a maintained die is small enough that a profile projector confirms it, and we specify it as a limit on the drawing rather than a vague note.

Where an edge must be rounded rather than broken, we add tumbling or electropolishing as a secondary operation.

Can you stamp titanium and beryllium copper?

Yes. We form TA1, TA2 and TC4 titanium, plus C110 and beryllium copper for contacts and electrodes.

These materials behave differently from stainless. Titanium springs back more, and beryllium copper needs its own tooling clearance. Both need a tool trial before we commit to a production rate.

How do you handle material traceability for an audit?

The heat number goes on the route card and follows the lot through stamping and finishing. Mill certificates are available on request.

If a customer needs certificates of conformance with the shipment, we raise them against the same lot records so the paperwork and the parts match.

Do you accept small runs or one-off prototypes?

There is no minimum order quantity. We run from a single prototype to 10,000+ part runs.

Prototypes are usually laser-cut or machined first, so the design is tested before die cost is committed.

What does the DFM analysis look like?

It comes back with the quotation within 12 hours. We flag features that cannot be stamped, strip layout options, and any tolerance that needs to be relaxed or inspected differently.

The goal is to move those decisions to the quoting stage, when changing them is still cheap.

How are drawings protected before an NDA is signed?

Uploads are secure and confidential. If your legal team needs an agreement in place first, a non-disclosure agreement is available on request before any file is sent.

We do not share customer drawings or part designs outside the project team.

Which inspections are performed before shipment?

Raw material check on receipt, in-process monitoring during the run, and final inspection before the box is sealed. Every shipment is 100% inspected.

Dimensional and surface reports are available on request. If a drawing calls out a specific characteristic, we record it.

Send the drawing. Get a stamping quote in 12 hours.

Upload your part files and get an instant quote with a free DFM analysis. No minimum order quantity, 100% inspection before shipment, NDA available on request.

12-hour quoteFree DFM100% inspectionNo MOQNDA available

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