Industry

Medical Devices manufacturing

Source precision-machined, moulded and additively manufactured components for medical device makers — from instruments and housings to implant-grade parts — with ISO 13485 discipline.

Key certification
ISO 13485
Precision features
±0.005–0.02 mm
Typical materials
316L, Ti Grade 5, PEEK
Documentation
FAI, 3.1, lot traceability

Overview

Medical device components combine small, precise geometries with strict process control and documentation. Depending on the device, parts may be surgical instruments, housings for diagnostic equipment, or implant components that contact the body. Material certificates, cleanliness, validated processes and full lot traceability are standard expectations.

The legal manufacturer of the device remains responsible for regulatory conformity, for example under the EU MDR. Component suppliers support that with a quality system suited to medical work, usually ISO 13485, and with the records needed for the device file.

On Metraxio you state materials, tolerances, certification and documentation requirements as part of the requirement. The platform checks which facilities fit before any supplier is invited, and keeps unknowns visible instead of guessing.

Typical parts & components

  • Surgical and dental instrument parts
  • Swiss-turned screws, pins and small precision parts
  • Housings and frames for diagnostic and lab equipment
  • Injection-moulded device housings and components
  • Orthopaedic and implant components (where qualified)
  • Additively manufactured prototypes and custom parts

The processes, materials and requirements below are an editorial reference of what is typical for medical devices programs — not a statement about facilities in the Metraxio network.

Common manufacturing processes

Typical materials & grades

Certifications & compliance

What buyers in this industry commonly ask suppliers for. Exact requirements depend on the program, customer and part.

Supplier certifications

  • ISO 13485 Typically required

    Typically required for critical device components.

  • ISO 9001 Common

    Accepted for some non-critical parts with extra controls.

  • ISO/IEC 17025 Sometimes requested

    Accredited testing or calibration laboratories.

  • ISO 14001 Sometimes requested

    Requested by some device makers.

Standards & regulations

  • EN 10204 Type 3.1 Common

    Material certificates for metallic parts.

  • REACH Common

    Substance compliance for the EU market.

  • RoHS Sometimes requested

    Electrical and electronic medical equipment.

Quality & documentation

  • Material certificates to EN 10204 3.1 and material standards for implant grades where applicable.
  • First article inspection and full dimensional reports.
  • Process validation (IQ/OQ/PQ) for special processes when required by the device maker.
  • Cleaning and, where specified, cleanroom packaging.
  • Lot traceability and change notification agreements.
  • Biocompatibility evidence (ISO 10993) remains with the device maker; suppliers provide material and process data.

Typical tolerances & surfaces

  • Precision turned and milled parts: typically ±0.005–0.02 mm on critical features.
  • Injection-moulded parts: typically ±0.02–0.1 mm depending on size and material.
  • Surface finish: often Ra 0.2–0.8 µm, with polished or passivated surfaces on instruments and implants.

Sourcing from Türkiye

Türkiye combines a deep contract-manufacturing base with short routes into Europe. Industrial goods move between Türkiye and the EU under the customs union, so buyers typically avoid EU import duties on qualifying parts.

  • Many European destinations can be reached by road within several days; actual transit depends on origin, destination, customs handling and cargo.
  • Common delivery terms are EXW, FCA and DAP; Metraxio keeps the agreed Incoterm attached to the quotation and order.
  • Plan time for first article approval and any process validation before series deliveries.

How Metraxio qualifies suppliers

Every request is checked against each facility's structured profile before any supplier is invited.

  • Hard criteria: the required process (e.g. Swiss turning, injection moulding), the specified material and grade, and required certifications such as ISO 13485.
  • Missing data is not a rejection. If a facility profile does not yet state something, the result is "Needs More Information" rather than "Not Qualified".
  • No match yet? You can continue with Managed Sourcing and the Metraxio team runs supplier discovery for you.
  • Facility identities stay anonymous during the technical assessment.

Example project

How a typical request moves through Metraxio

Titanium Grade 5 Swiss-turned screws — 2,000 pcs with first article inspection.

  • The buyer uploads drawings specifying Ti-6Al-4V (Grade 5), passivation, ISO 13485 and a first article inspection report.
  • Metraxio structures the requirement: CNC turning, titanium Grade 5, surface treatment, certification, quantity.
  • The fit assessment separates qualified facilities from those that need more information, for example an ISO 13485 certificate not yet on file.
  • The buyer invites qualified facilities to quote, or hands the job to Managed Sourcing.
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Frequently asked questions

Is ISO 13485 required for every supplier?

Most device makers expect ISO 13485 from suppliers of critical components. For non-critical parts some accept ISO 9001 with additional controls. State the requirement so it is assessed as a hard criterion.

Who is responsible for EU MDR conformity?

The legal manufacturer of the device. Component suppliers support the device file with material certificates, inspection records and process information.

Can suppliers make implant components?

Some facilities are set up for implant-grade materials and validated processes. Specify the material standard and documentation you need.

Which materials are common?

Stainless 316L and 17-4 PH, titanium Grade 2 and Grade 5, cobalt-chrome alloys and PEEK are common, depending on the application.

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Start a Manufacturing Project

Describe your medical devices part, attach drawings and see which facilities are a technical fit before you request quotes.