How medical device customers use us
We're a contract manufacturer that supports medical device developers through the R&D, design validation, and regulatory submission phases. We're not a finished-device contract manufacturer for market distribution — that role sits with ISO 13485–certified suppliers. But for the years between "CAD finished" and "we've selected a production CM," our fast-turn machining, material sourcing, and documentation discipline fill a gap that pure production shops don't.
Typical project types: implant trial components (fit testing, surgeon feedback), surgical instrument machining (in PPSU, PEEK, 316L stainless, or Ti Grade 5), autoclavable enclosures and trays, 510(k) submission sample batches, and bridge production while the customer qualifies their final contract manufacturer.
Material sourcing and traceability
For medical work, material traceability is as important as dimensional accuracy. Every lot of stock we receive is checked against the mill cert, tagged with an internal lot number, and tracked through machining to shipping. When your parts arrive, the FAI report and Certificate of Conformance reference the specific mill lot. If you ever need to investigate a field failure, the traceability chain is intact.
For implant-grade stock (PEEK-OPTIMA®, Ti-6Al-4V ELI per ASTM F136), we source direct from certified mills (Invibio, TIMET, ATI, Baoji Titanium) on a per-project basis with a customer purchase order. Certificate chain is preserved from mill → us → customer.
Surgical instruments and handles
Surgical tool handles, retractors, scopes, and forceps are a steady workflow. Materials are typically 316L or 17-4 PH stainless (passivated per ASTM F86) or PPSU (Radel R-5500) for autoclavable grip handles. We machine, bead blast, passivate or polish, laser-mark with part number and lot, and ship double-bagged in cleanroom poly.
For ergonomic handle designs with complex curvature, we run 5-axis machining on our Beijing Jingdiao JD500 cells. Typical tolerances are ±0.05 mm for cosmetic surfaces, ±0.02 mm for mating interfaces. See our CNC machining page for full envelope and capability.
Implant trial components
"Implant trial" usually means non-implantable components used during surgery to verify size, fit, or feel before the actual implant is placed. We produce trial hip stems, trial spinal cages, trial bone plates, and trial screw sets in Ti Grade 5 or PEEK (non-implant-grade for trials, implant-grade if testing regulatory chain). Each trial set is engraved with size code and lot number.
For actual permanent implants intended for market distribution, customers need an ISO 13485-certified contract manufacturer — we're not that supplier. But for R&D implant prototypes used in cadaveric testing, surgeon feedback sessions, and submission samples, our process and traceability are appropriate.
Autoclavable housings and trays
Device enclosures that need to survive repeated autoclave sterilization (134 °C steam) must be made from PEEK, PPSU, Ultem, or 316L stainless. Polycarbonate enclosures, common on lab-only devices, craze and embrittle after 50 or so autoclave cycles. PPSU is our recommended default for autoclavable housings — see the PEEK materials page for detailed grade selection.
Documentation we ship with every order
- First Article Inspection (FAI) report with full dimensional verification against your drawing
- EN 10204 3.1 mill certificates for all metals; polymer Certificate of Analysis (CoA)
- Certificate of Conformance (CoC) signed by our QA manager
- Lot number traceability from stock to finished parts
- RoHS/REACH compliance statement on request
- Biocompatibility statement (for implant-grade stock — as supplied by the mill)