Traceability is the deliverable

Custom Metal Components for Medical Device Manufacturers

Custom 316L stainless steel medical device components — instrument housings, trays, brackets and deep drawn enclosures in 316L and titanium, produced with heat-lot traceability, documented inspection and surface finishes compatible with your cleaning validation.

316L — Primary grade
EN 10204 3.1 — Mill certificates
Heat lot — Full traceability
ISO 9001 — Certified system

Traceability from heat number to shipment

Every 316L batch is recorded against its mill heat number at incoming inspection and carried through production to the packing list. When your QA asks where a part came from, the answer is a document, not a phone call.

Surface finish specified against cleaning, not appearance

Passivated, electropolish-ready, brushed or mirror — the right finish depends on your cleaning and sterilisation protocol. Specify the requirement and we build to it rather than assuming a cosmetic standard.

What we are, and what we are not

XCWY holds ISO 9001:2015. We are not an ISO 13485 certified supplier. We manufacture components to your drawings and quality requirements, supply material and inspection documentation, and support your qualification process — but the device-level regulatory system stays yours.

Specifications

Primary materials	316L, 316, 304L stainless; titanium Grade 2
Typical processes	Deep drawing, precision stamping, 5-axis machining, laser welding
Machined tolerance	Down to ±0.005 mm on the HDL-OKK DMU38
Material documentation	EN 10204 3.1 mill test certificates on request
Surface treatment	Passivation, brushing, polishing to specified Ra
Certification held	ISO 9001:2015 · 34025Q30296R0S (not ISO 13485)

FAQ

Is XCWY ISO 13485 certified?

No. We hold ISO 9001:2015, registration 34025Q30296R0S, verifiable at cnca.gov.cn. We manufacture components to your drawings and quality requirements and supply material and inspection documentation, but we are not a certified medical device supplier. If your programme requires an ISO 13485 supplier, tell us at RFQ so you are not surprised during audit.

Can you provide material traceability to heat lot?

Yes. Material is recorded against its mill heat number at incoming inspection and carried through to the packing list, with EN 10204 3.1 certificates supplied on request at no additional charge.

Why choose deep drawing over a welded housing for medical parts?

A drawn shell has no weld seam. That removes a crevice where contaminants can lodge, eliminates weld-zone corrosion risk, and usually simplifies cleaning validation. Where geometry permits, we recommend drawing over fabrication for this reason.

What surface finishes do you offer for medical components?

Passivation for stainless, brushing to a specified grit, and polishing toward a mirror finish. Specify Ra or supply an approved sample — "polished" without a number means different things to different suppliers.

Do you supply first article inspection reports?

Yes, on every order. For medical components we recommend agreeing the critical dimension list at DFM so the FAI report covers exactly what your QA team needs to release the batch.

Can you work with titanium?

Yes, Grade 2 titanium is machined on our 5-axis centre. Note that titanium deep drawing typically needs heated tooling and has a lower limiting draw ratio (around 1.6–1.8) than stainless, so send the geometry for assessment before assuming it is drawable.