What Medical Work Demands From a Machine Shop
Device shops do not need a supplier who owns a cleanroom — they need one whose parts survive theirs. In practice that means four things:
- Burr-free, chip-free features. Burrs inside a lum or at a cross-hole are the classic rejection reason. Cross-holes are deburred by method, not by an afterthought at the bench.
- Material compliance. Bar stock comes with mill certificates, so the PEEK, titanium or 316L in the drawing is the material in the part — traceable to the heat number.
- Surfaces that survive sterilization. Autoclave cycles punish trapped fluids and incompatible coatings; we flag geometries and finish choices that collect or trap before quoting.
- Batch traceability and documentation. Per-batch dimensional reports, material certificates and a Certificate of Conformance on request — your quality system needs the paper trail, so we produce it as standard.
Medical Parts We Machine
Representative part families and the control points that decide whether they pass:
| Part | Common materials | Process | Key control point |
|---|---|---|---|
| Surgical instrument handles & shafts | 316L, 17-4 PH, titanium | Swiss turning, milling | Edge break quality; surface finish for grip and cleaning |
| Endoscope & probe housings | 316L, PEEK, POM | Milling, some turning | Seal faces; thin-wall stability |
| Diagnostic equipment components | 6061, 303 stainless, POM | Milling | Fits and datum consistency across service parts |
| Test fixtures & assembly jigs | 6061, Delrin/acetal | Milling | Positional accuracy of locating features |
| Microfluidic & lab-on-chip substrates | PMMA, COC, PEEK | Milling (micro features) | Channel edge quality; flatness for bonding |
| Drug-delivery mechanism parts | POM, PEEK, 316L | Turning + milling | Burr-free sliding surfaces; dimensional report per batch |
Machining is the core process, but not the only one: early-stage device prototypes often start with 3D printing for geometry checks, and instrument trays and housings may be better served by sheet metal fabrication. We will say when a part does not need to be machined.
A Note on Materials & Compliance
We machine medical-grade polymers and metals — PEEK, POM, titanium, 316L — from certified stock. What we deliberately do not claim: we are not an ISO 13485 certified manufacturer and we do not assemble or package sterile devices. Where our role ends and yours begins is a conversation we have at quoting, not after a rejection — many device customers use us precisely for machined components and in-house fixtures, with validation handled on their side.
Quality & Inspection
First article on every new part number, dimensional report with every batch, mill certificates with the raw material, CoC on request. Inspection evidence is part of the delivery, not an add-on invoice.
Common Questions
Can you machine PEEK for parts that will be sterilized?
Do you provide material certificates with the parts?
We need 25 parts for design verification, then more later. Can you hold the spec across batches?
Can you hold the tolerances on our instrument shafts?
Are you ISO 13485 certified?
Machined parts for a device program?
Upload STEP/IGES or a 2D drawing — we reply with a quote, DFM feedback and the documentation plan for your quality system.
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