Medical Device Components

MedCNCParts machines medical device components to your drawing for device OEMs, equipment makers and the contract manufacturers that build their devices.

  • Made to your drawing
  • FAI report on request
  • Lot traceability
  • Samples to production
Introduction

Medical device components made to print

Every part is made to print in stainless steel, titanium, PEEK, PPSU, aluminum or a clear engineering plastic, then inspected and shipped with lot traceability, with material certificates on request, under an ISO 13485 quality system.

As a medical device component manufacturer, we take medical components from engineering samples and pilot builds to repeat production on the same approved process. For the processes behind these parts, see our medical CNC machining services.

  • Made to your drawing and specification
  • FAI report on request
  • Traceability from bar or plate to part
  • Material certificates on request
ISO
13485 quality system
Products Intro Image
Families

Medical machined components by device family

Diagnostic, surgical and equipment components first, then structural, fluid and motion parts; implant and orthopedic components come last, as an additional capability.

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Materials and standards for medical device parts

Materials and standards for medical device parts
316L / 316 stainless steel316L, 316LVM (ASTM F138); fluid, instrument parts
Instrument stainless17-4PH, 420, 440A per ASTM F899; shafts, jaws
TitaniumTi-6Al-4V; lightweight, high-strength parts
PEEKMachining grades, or ASTM F2026 when specified
Aluminum6061, 7075; housings, brackets, structures
Polycarbonate, acrylic, PPSUPer drawing; fluidic blocks, windows, handles
Process

From drawing to documented lot

  • Machining
  • Documentation
  • Inspection
  • Finishing
  • Machining

    DFM to repeat production

    Every part starts with a drawing review and DFM before the quote: tolerances, datums, materials and finishes checked, cost and risk drivers flagged, critical features agreed. We machine the grade on your drawing.

    Medical component manufacturing moves from engineering samples, measured in full, to a pilot build with dedicated fixtures and a fixed routing, then to repeat production on the approved process.

  • Documentation

    Working with OEMs

    An OEM medical device manufacturer, or the contract manufacturer building for it, needs the same part, documented the same way, on every lot. Our ISO 13485 certified machining is organized around that: no change of process, material or supplier without notifying you first.

    Medical device component manufacturing, seen from your supplier quality team, comes down to build to print and records you can audit. Your device falls under 21 CFR Part 820 (QMSR); we work under your supplier controls.

  • Inspection

    Inspection and records

    First article inspection (FAI) against the full drawing comes before process release, with the FAI report for your approval on request. Critical dimensions are inspected, with CMM reports on request where the drawing calls for them. Each lot ships with lot traceability; the CoC, mill test reports and 8D reports for closed nonconformances are on request.

    Biocompatibility is evaluated by the OEM on the finished device under ISO 10993-1.

  • Finishing

    Finishing and marking

    Parts can ship finished and marked, ready for your incoming inspection: passivation of stainless parts per ASTM A967 / A967M or ASTM A380, as the drawing calls out; electropolishing per ASTM B912; medical polishing, with the finish agreed on a sample.

    Titanium anodizing and coloring for color identification, or AMS 2488 Type II anodizing against galling; UDI laser marking of part, lot, serial and UDI data under 21 CFR 801.45.

  • 01
    Electropolishing
  • 02
    Passivation
  • 03
    Electroplating
  • 04
    Laser Marking
  • 05
    Anodizing
  • 06
    Titanium Coloring
  • 07
    Powder Coating
  • Electropolishing Featured Image

    Electropolishing medical metals produces smooth, clean, corrosion-resistant surfaces, removing burrs and impurities to ensure biocompatibility, sterility, and reliable device performance.

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  • Passivation Featured Image

    MedCNCParts provides medical CNC parts with precision passivation, removing contaminants and restoring stainless steel’s oxide layer for corrosion-resistant, implant-ready components.

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  • Electroplating Featured Image

    Precision electroplating for medical devices strengthens surfaces, maintains biocompatibility, and ensures clinical-grade, ISO-compliant, traceable finishes for implants and surgical instrumentation.

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  • Laser Marking Featured Image

    MedCNCParts provides precise, compliant laser marking and UDI on medical components, ensuring traceability, regulatory adherence, and long-lasting surface quality.

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  • Anodizing Featured Image

    Anodizing components for medical use strengthens surface protection, cleanliness, and biocompatibility, ensuring durable, traceable, and implantable-grade finishes for precision-machined parts.

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  • Titanium Coloring Featured Image

    With MedCNCParts’ titanium coloring, medical devices gain validated biocompatibility, precise differentiation, and assured compliance with stringent implantable certification standards.

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  • Powder Coating Featured Image

    Biocompatible powder coating creates corrosion-resistant, uniform finishes on medical parts, maintaining micro-precision, cleanliness, and validation-ready surfaces for surgical devices.

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  • 01
    Titanium
  • 02
    Acrylic
  • 03
    Stainless Steel
  • 04
    Copper
  • 05
    Aluminum
  • 06
    PEEK
  • 07
    Polycarbonate
  • Titanium Featured Image

    MedCNCParts offers precise, fast-turnaround CNC machining titanium with implant-grade quality, ultra-clean operations, and reliable small-batch medical part production.

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  • Acrylic Featured Image

    MedCNCParts’ machining services deliver precision-shaped components with refined finish, durability, and consistent optical performance for healthcare use.

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  • Stainless Steel Featured Image

    MedCNCParts offers advanced CNC machining for medical components, producing stainless steel parts for surgical and implantable applications to exacting ISO tolerances with fast turnaround.

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  • Copper Featured Image

    MedCNCParts’ CNC machining Copper ensures ISO 13485-certified cleanliness, precise tolerances, and consistent quality across surgical, diagnostic, and implantable copper components.

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  • Aluminum Featured Image

    MedCNCParts focus on traceability, process compliance, and rapid-response production makes us a trusted partner.

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  • PEEK Featured Image

    MedCNCParts machines PEEK components using validated processes, micro-precision, and complete inspection for advanced medical devices.

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  • Polycarbonate Featured Image

    MedCNCParts ensures consistent quality and fast turnaround for complex, small-batch medical applications.

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Industries

Where these components are used

Orthopedic, dental, surgical and diagnostic device programs source these parts to drawing, from engineering samples to repeat production, with records supplied on request.

Medical Device Components FAQs

FAQs

Send your drawing with the material, quantities and documents you need.

Request A Quote

MedCNCParts manufactures components to customer specifications; it does not design or market medical devices.

What are medical device components?

They are the individual machined, molded or formed parts that an OEM assembles into a finished device, such as a diagnostic manifold, an instrument shaft or an endoscope housing. We machine metal and polymer components to the OEM's drawing.

Do you sell standard or catalog parts?

No. Every part is made to the customer's drawing and specification; there is no catalog and no replacement-parts offer.

Can you work under our quality agreement?

Yes. ISO 13485 suppliers usually sign a quality agreement covering change notification, records retention and audits, and we work to the one your quality team issues.

What volumes do you support?

From engineering samples and pilot builds to repeat production runs of 10,000+ parts.

Which documents can come with each lot?

On request, we supply the documents your program needs: a CoC, material certificates with heat or lot traceability, an FAI report on first articles and inspection data on critical dimensions. Parts are made under an ISO 13485-certified quality system.

Do you supply contract manufacturers?

Yes. We supply machined components to OEMs and to the contract manufacturers that build their devices, under the requirements the medical device OEM manufacturer flows down.

Are your parts biocompatible?

Biocompatibility is evaluated by the OEM on the finished device (ISO 10993-1). We supply the specified material, with material certificates on request, and the specified cleaning and passivation.