Medical device machining means producing a part that must be provable, not just accurate. The tolerance is only half of the requirement; the other half is the documented chain from material lot to inspection result to the box that left our floor. That chain is what we build into the process from first article onward.
Part families
What we machine and mold for medical customers
| Part family | Process | Typical material | Critical requirement |
|---|---|---|---|
| Device housings | Injection molding, 2–8 cavities | PC, ABS, POM, PEEK | Clean parting line, dimensional report per cavity |
| Fluid-path components | 5-axis machining | 316L stainless, PEEK, PTFE | Bore roundness, Ra 0.4 µm, no trapped residue |
| Instrument bodies | 3- and 5-axis machining | Aluminium 6061, 7075 | Datum repeatability, anodised finish consistency |
| Fixtures and test jigs | Machining | Aluminium, tool steel | Flatness 0.01 mm, gauge-ready surfaces |
| Prototype devices | Prototype tooling, low-volume machining | Same as production | Material truth for clinical evaluation |
Lot traceability, step by step
Give us a part or a box label and we can produce the record for that lot within one working day — material, process and inspection in one document set.
Inspection pack per batch
- First article inspection report against the ballooned drawing, with actual readings
- CMM report stating the datum scheme, the program revision and probe qualification date
- Surface roughness reading on sealing and fluid-contact faces
- Material certificate matched to the lot number
- Cleanliness note covering deburring, washing and packaging method
- Certificate of conformity signed against the drawing revision you supplied
What we do not claim
We are a toolmaking and machining supplier, not a certified medical device manufacturer, and we do not issue regulatory clearances. What we do is produce parts and the manufacturing records that support your own quality system — and state in writing which certifications we hold before you place an order.
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Medical machining FAQ
Can you keep a part traceable to a single lot?
Yes. Each lot gets a number that links the material certificate, the machine and operator, the inspection results and the shipment. Given a part or a box label, we can pull the full record for that lot.
Do you inspect 100 % of medical parts?
If the drawing names critical features, we can inspect them 100 % and quote the inspection time as a separate line, so you see what full inspection costs before you approve it. Otherwise the inspection plan uses the sampling frequency you state.
Can you machine PEEK and other engineering polymers?
Yes. PEEK, PTFE, POM and PC are routine. We machine them with sharp, dedicated tooling and controlled coolant to avoid surface smearing, and we state the achievable finish rather than promising the drawing blindly.
How do you handle design changes after first article?
Every change gets a revision that applies to the model, the program and the inspection plan together, so the record you receive always matches the drawing revision it was measured against.
Parts you can prove, not just parts you can measure
Send the drawing and tell us which records your quality system needs. We confirm both in one reply.
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