Drawing-controlled CNC machining and grinding for medical device components, with inspection and documentation agreed before production starts.
A medical device component is ordered against a released drawing revision, and the revision matters. Two parts that look identical on screen can differ by a chamfer, a radius callout or a surface note that changes how the part has to be machined and inspected. The first thing we do with a medical enquiry is confirm which revision we are quoting, and flag anything on the drawing that will be difficult to hold — before the quote goes out, not after the first article.
Most of this work is not exotic geometry. It is a housing, a bracket, a shaft, a manifold or a fixture, machined accurately and delivered with the inspection evidence your quality system expects. What separates medical work from general machining is the discipline around the drawing and the paperwork, not the shape of the part.
Different features go to different machines. We pick the route by geometry, material and quantity rather than by habit.
Achievable tolerance depends on the feature, the material and the route. Turning and milling hold one limit, grinding holds a tighter one on suitable features, and a feature that is straightforward in aluminium may need a ground operation in hardened steel. Send the drawing and we will confirm which features we can hold, and by which process, during engineering review.
The material usually follows from what the part touches and how it is cleaned.
We machine what the drawing calls out. If the grade is left open, send the application and the operating conditions and we will recommend one — the choice is confirmed during engineering review rather than guessed at quote stage.
Most medical programmes start with a small quantity to prove fit and function, then move to repeat orders once the design is fixed. We run both on the same process, which matters: the part you validate should come off the same setup and the same inspection plan as the part you buy in volume.
What comes with a medical order is agreed at RFQ, not assumed. Tell us which dimensions are critical, whether you need a dimensional report per batch or per first article, and what material documentation your quality system requires. We confirm what we can provide before the order is placed, so nothing is discovered at delivery.
See Quality & Certifications for how inspection is built into the process. Certificate documentation available on request.
Our ISO 13485 certification was registered for machining of hardware. That is the scope that applies to a machining supplier: it describes the quality management system under which machined components are produced.
It is not a product approval, and it does not extend to product design or to your own device-level validation — those stay with you. If your supplier qualification needs the certificate and its scope statement, ask for it with the RFQ and we will send the current documentation with the quote.
Send the released drawing revision — a 2D PDF and 3D CAD if you have both — together with the material grade, the quantity you need now and the quantity you expect later, the critical tolerances and features, the finish callout, and the inspection or documentation your quality system requires. Add the delivery date you are working to. Our engineers review the drawing before quoting and come back with questions if anything on it is ambiguous. See How It Works for what happens between the quote and the first delivery.
Everything an engineer needs to quote without guessing.
How we handle drawing control, traceability and documentation on medical device components — and what the certificate covers.
Drawing review, process planning and ongoing development work for Ivo USA.
Read the Ivo project account →
InspectionCritical features are measured in our metrology lab against the drawing, and the report that goes out with the batch is the one agreed at RFQ.
We machine components to the customer's released drawing and specification. Whether a part is patient-contacting or implantable is determined by your design, your material choice and your regulatory pathway, not by a machining supplier. If your part falls into that category, tell us at RFQ so the material documentation and the inspection plan can be agreed up front.
It was registered for machining of hardware. That is the scope that applies to a machining supplier: it describes the quality management system under which machined components are produced. It is not a product approval, and it does not extend to product design or to your own device-level validation.
A revision change is treated as a new review. Send the new revision and tell us what changed; we check whether it affects the process, the tooling or the inspection plan, and re-quote if it does. We do not machine to a superseded revision and we do not apply an edit silently.
It depends on the feature, the material and the process route. Turning and milling hold one limit; grinding holds a tighter one on suitable features, and a feature that is straightforward in aluminium may need a ground operation in hardened steel. Send the drawing and we will confirm which features we can hold and by which process during engineering review.
Material documentation and dimensional inspection reports are available, and what is supplied is agreed at RFQ so it matches what your quality system expects rather than what is convenient for us. Tell us at quote stage whether you need documentation per batch or per first article. Certificate documentation available on request.
Upload your 2D drawing and 3D CAD, the material and quantity, the critical tolerances and features, the finish, and the inspection or documentation you need. Our engineers review every request personally and come back with questions before a price.