ISO 13485 machining at MedCNCParts runs every component we make to your drawing through one documented quality system. For device OEMs and contract manufacturers: controlled drawings, certified material, FAI and lot traceability, reports on request.
MedCNCParts, the medical division of DEK, machines components to the drawings of device OEMs, equipment manufacturers and contract manufacturers. Every order runs through one documented quality system, certified to ISO 13485 and ISO 9001, that covers all our medical CNC machining services.
Our scope is the component. The OEM owns design validation, ISO 10993 biological evaluation, sterilization validation and regulatory clearance (510(k), PMA or CE marking).
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.
| Certificate of Conformance | On request, every lot: part number, revision, lot, quantity, conformance to drawing and PO |
| Material certificate (MTR) | On request, every lot: mill test report traced to the heat or lot used |
| FAI report | On request, first article and after a change: every drawing characteristic recorded |
| Inspection or CMM report | On request, per the agreed inspection plan: results on critical dimensions |
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.
Before we accept an order, contract review checks the drawing, revision, material, finish, quantities and the documents you need. Only the released revision reaches the machines.
A new revision means a new review and, where the part changes, a new first article.
Material is bought to the specification on your drawing, with mill certificates available on request. The heat or lot number follows the material from cut-off to shipped part.
A process traveler records routing, programs, fixtures and inspection steps, so every repeat lot runs the process you approved.
First article inspection (FAI) measures the first parts against the full drawing before production is released; the FAI report is supplied on request. In-process checks then cover the features agreed at DFM review.
Quality is built into the process through first-piece approval, in-process checks and tool-wear control, rather than left to final inspection.
A nonconformance triggers an NCR, segregation and disposition, then corrective and preventive action (CAPA).
At release, a Certificate of Conformance is available for each lot, on request, and the records stay tied to your part number and lot.
The certificate covers our quality management system, not individual parts: we are certified to ISO 13485:2016, medical devices quality management systems, and to ISO 9001:2015. No other certification or registration is claimed for MedCNCParts or for its parts.
Your supplier quality team can check the certificate data (body, number, scope, sites and expiry date) before you send a drawing.
ISO 13485:2016 clause 7.4 requires a device manufacturer to evaluate, select and monitor its suppliers in proportion to risk. In the U.S., 21 CFR Part 820 (QMSR), in force since February 2, 2026, incorporates ISO 13485:2016 by reference; EU OEMs work under (EU) 2017/745 (MDR).
An ISO 13485 contract manufacturer of components supports your purchasing controls with a supplier questionnaire and certificate copies, notification before any change of process, material, supplier or site, and flow-down of the OEM's requirements into the purchase order. See component contract manufacturing.
When you shortlist ISO 13485 certified companies, check scope, certification body and validity before you compare prices. The scope must cover your part type and its processes (machining, finishing, marking); the certification body must be one you can verify, and the certificate current, naming the factory that will make your parts.
Ask which specification applies to passivation, heat treatment or plating, and for a sample CoC, FAI report and inspection report, all on request, before the first order. See our quality control system and quality assurance in medical manufacturing.
Send your drawing, material, quantities and the documentation you need, all supplied on request.
MedCNCParts manufactures components to customer specifications; it does not design or market medical devices.
A documented quality system with risk-based process control, supplier control, traceability, nonconformance and CAPA handling, and records. For a machining supplier this shows up as controlled drawings, certified material, inspection records and lot traceability, with a CoC for each lot on request.
No. ISO 13485 follows the structure of ISO 9001 but adds regulatory, risk, validation and documentation requirements specific to medical devices. We are certified to both.
No. Parts are not approved or cleared; the OEM's device is, through the OEM's own submission. ISO 13485 shows that the supplier's quality system meets the medical device standard.
Yes, supplier quality teams can audit us on site or remotely, by appointment.
On request, we supply the documents your program needs: a CoC and material certificates for each lot, an FAI report on first articles and inspection data on critical dimensions. Parts are made under an ISO 13485-certified quality system.
The scope statement printed on the certificate defines it. Finishing and marking are applied per the drawing's callout and controlled under the same quality system.
