Medical Device Parts

Instrument trays, cart bodies, sterilisation housings and diagnostic device shells — 316L stainless and documented quality systems for parts that get audited.

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Medical device parts inspected in the metrology laboratory
ISO 13485QMS available
316LStandard material
RoHS / REACHDeclaration issued
FullTraceability pack
Why Pengfeng

Three Things That Decide Whether This Part Works

We do not claim to be the cheapest metal shop in Asia. We are the one that lets you stop managing your supply chain.

/01

Documentation That Answers Audits

Our records were noted as a strength by an external auditor. Certificates, dimensional reports and risk-management documentation ship with the batch.

/02

Cleanability By Design

Surfaces that do not trap contamination, and corner radii we will recommend even if your drawing shows a sharp internal edge.

/03

316L as Standard, Not Upgrade

Most medical work we run is 316L or a specified polymer. We will tell you when 304 or plain mild steel is genuinely enough.

How We Help

From Prototyping to Production

The same five stages whether you order one sample or 500,000 pieces.

01

Prototyping

Get parts for early-stage development. We use low-cost materials and processes to make samples that behave like the final product, so your design iterations are cheap and fast.

  • Rapid material and design iterations
  • Detailed prototypes for complex geometry
  • Models that resemble final parts
02

Engineering Validation

Functional prototypes that let you identify every design risk before you commit to tooling. Where needed this takes several iterations to hit the required performance metrics.

  • Precision parts manufacturing
  • Reliable design and engineering support
  • Optimised material properties
03

Design Validation

Validate function, performance and appearance. This is where material and finishing choices get decided — the point where a part starts looking and feeling right.

  • Parts for market and field testing
  • Performance and appearance validation
  • Durable, repeatable finishes
04

Production Validation

Prepare for full-scale production with production-grade tooling and quality control. Verify the process before you order volume.

  • Low-volume production tooling
  • Verification of manufacturing processes
  • Functionality of production-ready parts
05

Volume Production

Move to end-use parts at volume. Our in-house tooling, SPC and inspection keep yield and quality high while lead times and unit costs fall.

  • Tight tolerances on precision parts
  • Secondary operations for surface finish
  • Rigorous inspection and QC
Materials & Surface Finishes

What We Run This Job On

Grades chosen for this sector's environment. Tell us if yours is not here — we source to spec.

Materials

  • •316L / 316 stainless
  • •304 stainless (mild exposure)
  • •Aluminium 6061 (anodized)
  • •Titanium Gr2 / Gr5
  • •PEEK / PEI / PSU
  • •PMMA for optical windows

Surface Finishes

  • •Passivation AMS 2700
  • •Chrome-free passivation
  • •Electropolish Ra ≤0.4
  • •Clear anodizing
  • •Bead blast (matte)
  • •Autoclave-compatible polymers
Applications

Common Medical Devices Parts We Manufacture

If your part is not listed, send the drawing — custom work is the majority of what we do.

  • Instrument trays and cassettes
  • Sterilisation baskets and containers
  • Surgical cart and trolley bodies
  • Diagnostic device housings
  • Bed rail and accessory clamps
  • Dental instrument components
  • Pump and valve bodies
  • Optical mounts and light guides
  • FAQ

    Questions We Get About Medical Devices

    Can you work to our ISO 13485 documentation requirements?

    Yes. We operate ISO 13485 for medical scope and can supply the supporting documentation package your quality system expects.

    Do you handle design control documentation?

    We support it — design history file inputs, risk analysis and verification/validation support on request.

    Send Your Medical Devices Drawing

    STEP, DWG or a photo. An engineer reviews it and returns a firm price within two working hours — with a manufacturability note attached.