We hold ISO 13485:2016 certification for the manufacture of hardware turned parts for medical devices (subassemblies) — certificate no. 39125M208006R0S, issued by Shenzhen Onelink Certification Center, valid until 24 August 2028.
In this sector the certification is usually the first filter, so it is worth being precise about what it covers. Our certified scope is turned hardware components for medical devices — not implants, and not finished devices. We machine the parts. Our customers integrate them, sterilise them, package them and take the device to market.
Typical Medical Components We Machine
Surgical instrument partsTurned handles, shafts and fittings for reusable instruments.
Sensor & probe housingsTurned bodies needing a close bore tolerance and a clean internal finish.
Connectors & couplingsSmall precision fittings for tubing and fluid paths.
Valve componentsBodies, stems and seats where concentricity actually matters.
Implant-adjacent hardwareNon-implant fasteners and inserts that go into device assemblies.
Instrument pins & shaftsSlender parts — usually a Swiss-type turning job.
Capabilities for Medical Work
| Certification | ISO 13485:2016 — certificate no. 39125M208006R0S, valid to 24 Aug 2028 |
|---|---|
| Certified scope | Manufacture of hardware turned parts for medical devices (subassemblies) |
| Also held | ISO 9001:2015 quality management system |
| Machining tolerance | ±0.01 mm standard |
| Surface roughness | Ra 1.6 |
| Materials | Stainless steel 303 / 304 / 316, brass, aluminum, engineering plastics |
| Records available | Dimensional report, first article inspection (FAI), material certificate, salt-spray and hardness testing |
| Minimum order quantity | 100 pcs per part number, prototypes from 5–20 pcs |
How a medical component order runs
Send the drawing together with the standard or specification the component has to meet. We review it before quoting and will tell you if something in it falls outside our scope — a feature, a tolerance, a material — rather than quote the job and find out later.
From Drawing to Delivery
- Send the drawing and the standardSTEP/IGES or 2D with tolerances, plus the applicable specification.
- Engineering reviewWe confirm feasibility, flag anything outside our certified scope, and quote.
- Sample and first articleSamples in about 7 working days, with a first article inspection report on request.
- ProductionAround 30 working days, confirmed per project, with in-process patrol inspection.
- Delivery with recordsParts ship with the dimensional report and material certificate.
What we do not do. We are a component manufacturer, not a device manufacturer. We do not sterilise, package for sterile presentation, or assemble finished devices — those steps sit with you or a specialist partner. What we will do is machine parts to the specification those later steps require, and tell you early if a requirement is beyond us.
Medical Device Components — Common Questions
Are you ISO 13485 certified?
Yes. Our quality management system is certified to ISO 13485:2016 (GB/T 42061-2022) for the manufacture of hardware turned parts for medical devices — certificate no. 39125M208006R0S, issued by Shenzhen Onelink Certification Center, valid until 24 August 2028. We also hold ISO 9001:2015 certification.
Do you make implants?
No. Both our certification scope and our process cover non-implant components — turned hardware used in instruments, devices and their assemblies. Implants bring regulatory and material requirements well beyond our scope.
What documentation can you supply with the parts?
Dimensional inspection report, first article inspection (FAI), material certificate, salt-spray test and hardness test. Tell us what your quality system requires and we will confirm what we can provide before you place the order.
Which materials do you machine for medical components?
Stainless steel 303, 304 and 316 are the most common, alongside brass, aluminum and engineering plastics. If your drawing calls for a material we cannot source reliably, we will tell you rather than substitute something close.
Can you sign an NDA before we send drawings?
Yes — send yours, or use ours, whichever your process requires.
Send the drawing and the specification.We will confirm feasibility and whether the applicable standard falls within our certified scope before quoting.Request a Quote →