Back

Industry · Life sciences

Medical Devices

Q: Are you ISO 13485 certified?

No — Wolfer is ISO 9001:2015 certified, not ISO 13485. We ship as a component supplier to ISO 13485 OEMs and provide all documentation those OEMs' quality systems require (mill cert, dimensional report, heat-treatment record).

Q: Do you provide material certificates?

Yes. EN 10204 3.1 mill certificates ship with every part by default. EN 10204 3.2 (with mill witness) is available on request — typically adds 1 week to lead time.

Q: Can you ship in biocompatible-grade stainless?

Yes — SUS304, SUS316L, SUS440C, 17-4 PH are routine. We do not perform passivation in-house but the surface finish we ship is pre-qualified for downstream passivation by the customer.

Precision transmission components for surgical robots, lab automation, and diagnostic equipment — built to medical-grade traceability.

Medical device makers need transmission parts that are precise, traceable, and made from biocompatible-grade materials. Wolfer ships custom gears, micro-shafts, and locking assemblies to surgical-robot OEMs and lab-automation builders worldwide, with material certificates and full inspection records on every part.

Request a Quote Talk to an engineer →

Precision class

ISO 1328 Class 5
Common stock

SUS304 / 440C / 17-4 PH
Documentation

Material cert + CMM report
Lead time

≤ 30 d after approval

What we ship

Parts we make for medical devices.

Surgical-robot joint reducers

Class 5 ground gears in stainless for low-backlash joint motion

Micro shafts

Ø 3 mm – Ø 12 mm precision shafts for instrument articulation

Lab-automation timing belt pulleys

Stainless or anodized aluminum pulleys for pipetting / scanning stages

Zero-backlash couplings

Bellows / diaphragm couplings for encoder-loop drives

Locking Assemblies

Replace keyed joints — eliminate backlash on rotating instrument shafts

Medical equipment is the most demanding home for our gears. Two reasons: the patient is in the loop, and the regulator is in the loop. Every part needs a documented material origin, a documented inspection record, and a heat-treatment record — so when an FDA / NMPA / CE auditor asks "where did this gear come from", the OEM can answer in one page.

We ship Class 5 ground gears in surgical-grade stainless (SUS440C, 17-4 PH), micro-shafts down to Ø 3 mm for laparoscopic instruments, and zero-backlash bellows / diaphragm couplings for laboratory pipetting robots. Every shipment carries the material certificate + CMM dimensional report.

We are not an ISO 13485 facility ourselves — but we ship to ISO 13485 customers and provide the documentation those customers' quality systems require.

Products this vertical buys

Linked to full product specs.

Each card opens the product detail page with full capability matrix, materials, and standards.

Stainless precision gears

ISO 1328 Class 5 ground, SUS304/440C/17-4 PH

View product →

Micro gear shafts

Ø 3 mm – Ø 12 mm, integrated gear + bearing journal

View product →

Zero-backlash couplings

Bellows · diaphragm — for encoder-loop motion

View product →

Stainless timing belt pulleys

HTD / GT, SUS304, with hard-anodized aluminum flanges

View product →

Engineering requirements

What makes medical parts different.

Material certificates

Mill certs (3.1 / 3.2 EN 10204) attached to every shipment

Biocompatible-grade alloys

SUS304, SUS316L, SUS440C, 17-4 PH — pre-qualified for downstream passivation

Surface for sterilization

Electroless nickel, electropolish, or Ra ≤ 0.4 mechanical polish

Backlash matters

Ground gears, zero-backlash couplings, locking assemblies

Documented inspection

CMM dimensional report + tooth-form check per part lot

Lot traceability

Bar-code lot codes track each shipment back to the steel heat number

Customers

Active medical customers.

A selection of internationally known names — the full list lives where it matters, in our shipping records.

SIASUN

UBTECH

BEAR ROBOTICS

Case studies

Representative outcomes.

< 5 arc-min backlash · 3,000 hr endurance

Surgical-robot articulation gears — ISO Class 5

Custom helical gear set for a 7-DOF surgical robot arm. Ground SUS440C, ± 0.005 mm pitch error, shipped with full CMM report.

0.05 mm positioning over 600 mm stroke

Lab-automation pipetting pulleys

Custom-bore HTD 3M pulleys in hard-anodized 7075 aluminum, drove a 96-well pipetting head for a Chinese clinical-diagnostics OEM.

FAQ

Common questions from medical buyers.

Are you ISO 13485 certified?

No — Wolfer is ISO 9001:2015 certified, not ISO 13485. We ship as a component supplier to ISO 13485 OEMs and provide all documentation those OEMs' quality systems require (mill cert, dimensional report, heat-treatment record).

Do you provide material certificates?

Yes. EN 10204 3.1 mill certificates ship with every part by default. EN 10204 3.2 (with mill witness) is available on request — typically adds 1 week to lead time.

Can you ship in biocompatible-grade stainless?

Yes — SUS304, SUS316L, SUS440C, 17-4 PH are routine. We do not perform passivation in-house but the surface finish we ship is pre-qualified for downstream passivation by the customer.

Related industries

Building medical equipment?

24-hour quote · engineering review within one business day · ≤ 30 days to ship after approval.

Upload your drawing Talk to an engineer →

This is a preview of the Medical Devices industry page

return to home preview

preview build

Medical Devices

Surgical-robot joint reducers

Micro shafts

Lab-automation timing belt pulleys

Zero-backlash couplings

Locking Assemblies

Stainless precision gears

Micro gear shafts

Zero-backlash couplings

Stainless timing belt pulleys

Material certificates

Biocompatible-grade alloys

Surface for sterilization

Backlash matters

Documented inspection

Lot traceability

Surgical-robot articulation gears — ISO Class 5

Lab-automation pipetting pulleys

Are you ISO 13485 certified?

Do you provide material certificates?

Can you ship in biocompatible-grade stainless?

Robotics

Laser Equipment

Semiconductor Equipment

Building medical equipment?