MedCNCParts provides medical device contract manufacturing at the component level: machined, finished and marked parts built to print for device OEMs and the contract manufacturers that build their devices.
MedCNCParts, the medical division of DEK, machines components to print for medical device OEMs and their contract manufacturers, then ships them finished, marked and documented under an ISO 13485 quality system (see ISO 13485 certified machining).
Much of what is sold as medical contract manufacturing covers the finished device (see what contract manufacturing for medical devices involves). Assembly, sterilization and registration stay with the OEM or its contract manufacturer.
All parts are custom, made to your drawing, in this order of focus.
Manifolds, optical and sensor housings, instrument and endoscope parts, machined to your drawing.
Fluidic blocks, sample-handling parts and sensor mounts, made to print.
Device housings, brackets and handles, machined and finished to your drawing.
Fittings, motion and transmission parts, made to your drawing and finish callouts.
As an additional capability: implant components, fixation components and medical fasteners.
The full list of medical device components we manufacture, each one made to print.
Electropolishing medical metals produces smooth, clean, corrosion-resistant surfaces, removing burrs and impurities to ensure biocompatibility, sterility, and reliable device performance.
MedCNCParts provides medical CNC parts with precision passivation, removing contaminants and restoring stainless steel’s oxide layer for corrosion-resistant, implant-ready components.
Precision electroplating for medical devices strengthens surfaces, maintains biocompatibility, and ensures clinical-grade, ISO-compliant, traceable finishes for implants and surgical instrumentation.
MedCNCParts provides precise, compliant laser marking and UDI on medical components, ensuring traceability, regulatory adherence, and long-lasting surface quality.
Anodizing components for medical use strengthens surface protection, cleanliness, and biocompatibility, ensuring durable, traceable, and implantable-grade finishes for precision-machined parts.
With MedCNCParts’ titanium coloring, medical devices gain validated biocompatibility, precise differentiation, and assured compliance with stringent implantable certification standards.
Biocompatible powder coating creates corrosion-resistant, uniform finishes on medical parts, maintaining micro-precision, cleanliness, and validation-ready surfaces for surgical devices.
MedCNCParts offers precise, fast-turnaround CNC machining titanium with implant-grade quality, ultra-clean operations, and reliable small-batch medical part production.
MedCNCParts’ machining services deliver precision-shaped components with refined finish, durability, and consistent optical performance for healthcare use.
MedCNCParts offers advanced CNC machining for medical components, producing stainless steel parts for surgical and implantable applications to exacting ISO tolerances with fast turnaround.
MedCNCParts’ CNC machining Copper ensures ISO 13485-certified cleanliness, precise tolerances, and consistent quality across surgical, diagnostic, and implantable copper components.
MedCNCParts focus on traceability, process compliance, and rapid-response production makes us a trusted partner.
MedCNCParts machines PEEK components using validated processes, micro-precision, and complete inspection for advanced medical devices.
MedCNCParts ensures consistent quality and fast turnaround for complex, small-batch medical applications.
| DFM review of the drawing | Yours: device design and design controls |
| Material sourcing | Yours: risk management (ISO 14971) |
| Milling, Swiss turning, 5-axis | Yours: biological evaluation (ISO 10993-1) |
| Wire and sinker EDM, grinding | Yours: device assembly, cleaning validation |
| UDI laser marking | Yours: sterilization, labeling, packaging |
| FAI and CMM reports on request | Yours: 510(k), PMA or CE marking submissions |
Drawing, tolerances, material and finish checked before the quote.
Grade bought to the drawing; certificates kept with the lot, on request.
Critical features checked, parts finished, marked and shipped with lot traceability.
First parts measured against the full drawing; report on request.
The approved routing, programs and fixtures on every lot.
Parts leave us finished to the drawing: deburring, passivation, electropolishing and titanium anodizing as the print calls for them. Finish callouts are checked at DFM review together with the drawing and tolerances.
UDI laser marking applies serial, lot and UDI data to the part for direct marking under 21 CFR 801.45.
As a component-level medical device contract manufacturer, we build to print: the released drawing revision is the contract, and deviations are raised before machining. We work under your quality agreement and support supplier qualification with questionnaires and certificate copies.
No change of process, material source, supplier or site without your approval. Each shipped lot traces to its material heat or lot, and every repeat order runs the same programs, fixtures and inspection plan.
Under ISO 13485:2016 clause 7.4 and 21 CFR Part 820 (QMSR), the device manufacturer controls its suppliers. Our quality systems, certified to ISO 13485 and ISO 9001, are built to plug into those controls.
First article inspection (FAI) comes before production is released. CMM reports on the characteristics you specify, the Certificate of Conformance and material certificates for each lot are supplied on request, as are NCR, CAPA and 8D reports when a nonconformance occurs.
Engineering samples are measured against the full drawing, with the FAI report available on request for your approval. The pilot or low-volume build then runs the approved process, fixtures and inspection plan as they will run in production.
Repeat orders keep the same routing and inspection plan on every lot, under change control, so the part you approved is the part you receive on each repeat lot.
Device OEMs source machined parts from us while keeping device assembly in their own plants or with their CM. You send the drawing and the requirements; we return parts and, on request, a first article report and the lot documentation your incoming inspection needs.
Contract manufacturers that build finished devices or instruments for OEMs buy machined components from us; drawing revision, material, finish, marking and documentation are confirmed per order at DFM review.
Supply risk comes from weak supplier control, not from buying components outside your plant. Buyers who qualify medical device contract manufacturers usually check:
Our guide on how to qualify a machining supplier lists the questions to ask.
When contract manufacturing medical devices at component level, there is no list price for a part made to print. Cost depends on:
More in cost factors in medical CNC machining; the same focus applies across our medical CNC machining services.
Send your drawing, material and quantities, and tell us which documents you need on request.
MedCNCParts manufactures components to customer specifications; it does not design or market medical devices.
The risk comes from weak supplier control. It is managed with an ISO 13485-certified supplier, a quality agreement, change notification, traceable records and FAI reports on request.
There is no list price: cost depends on material, tolerances and inspection level, finishing, volume and documentation. Send a drawing and your annual volumes for a quote.
No. MedCNCParts supplies machined, finished and marked components; assembly, sterilization and regulatory submissions stay with the OEM or its contract manufacturer.
Yes. Contract manufacturers that build devices for OEMs can source machined components from us, with the OEM's requirements flowed down to the purchase order.
Yes, both can be signed before drawings are shared.
Yes. On request, we supply FAI reports, inspection data and, when your program requires it, IQ/OQ/PQ documentation for the machining process.
From engineering samples and pilot builds to repeat production of 10,000+ parts.
