Precision components for surgical, orthopedic, dental and diagnostic devices. Ti-6Al-4V, SS 316L and PEEK with 5-axis tolerance to ±0.005 mm. ISO 13485-ready process and full mill traceability — quote within 24 business hours.
Medical components are unforgiving — the wrong burr, the wrong supplier, the wrong paperwork can ruin a regulatory submission. The factory behind this domain has spent six years building an export-grade quality system specifically for medical, semiconductor and aerospace work, with documented FAI, full traceability and customer audits welcomed.
Quality system designed ISO 13485-ready: documented FAI per part number, lot traceability to raw material heat number, PPAP Level 3 on request, and full participation in customer quality audits.
Implant-grade titanium Grade 5 with ASTM F136 documentation, electropolished 316L stainless, and medical-grade PEEK — supplied with mill certs traceable from heat number to finished lot.
5-axis machining to ±0.005 mm linear, H6 bore, h5 shaft, IT5 grade. GD&T including profile, runout and concentricity is verified on CMM with reports issued per shipment.
Most medical RFQs sit in a queue waiting for a quote. The workflow below targets a 24-business-hour first response and a 2–3 week prototype lead time including FAI, so engineering teams can iterate without losing a sprint.
Mutual NDA signed before any file is opened. STEP, PDF and DWG drawings reviewed by an engineer; DFM feedback returned with the quote at no charge.
RFQ response within 24 business hours with itemized pricing, lead time, material certificates list and inspection plan. No tooling charge for prototype quantities under most cases.
1–10 piece prototypes machined on 5-axis with full First Article Inspection report. CMM verification of every called-out dimension before any second-piece runs.
Validated process locked, lot-controlled production starts. Each shipment includes mill certs, FAI report, and dimensional inspection at the agreed AQL or 100% inspection level.
The shop runs from raw bar to finished, passivated part. Material is purchased with mill certificates and stored with lot identification; nothing leaves the building without traceability matching the certificate of conformance.
Ti-6Al-4V to ASTM F136 — implants, surgical instruments, dental abutments.
Commercially pure titanium — non-load-bearing implants and housings.
Implant-grade stainless — electropolished and passivated per ASTM A967.
Surgical instrument bodies, hardenable to required HRC range.
Medical PEEK and PEEK-CF — spinal cages, instrument handles, wear parts.
Diagnostic equipment housings, fluid-handling components, valve seats.
| Linear (best) | ±0.005 mm |
| Linear (typical) | ±0.01 mm |
| Bore tolerance | H6 |
| Shaft tolerance | h5 |
| IT grade | IT5 |
| Surface roughness Ra (best) | 0.8 µm |
| Surface roughness Ra (typical) | 1.6 µm |
| GD&T | Flatness, profile, runout, concentricity, perpendicularity |
| Inspection | CMM, optical comparator, height gauge — FAI included |
| Secondary processes | Passivation, electropolish, anodizing Type II/III, laser marking |
The shop is not chasing simple 2D parts. The work that lands here is what falls out of design reviews when an engineer says this needs 5-axis and we need it traceable — small to medium components where dimensional integrity and documentation both matter.
Forceps, retractors, drivers, drill guides, cutting blocks. 17-4 PH and 316L bodies with crisp edges, controlled radii and surgical-grade finish requirements.
Bone screws, plate trial components, instrument cases, fixation hardware. Ti Grade 5 from ASTM F136 stock with full lot traceability for regulatory submission.
Dental abutments, scanner housings, fluid-handling manifolds, optical mounts. Mixed-material assemblies welcome — Ti, SS and PEEK in the same bill of materials.
Our process is built ISO 13485-ready: documented FAI, full mill certs, lot traceability, and PPAP Level 3 on request. Formal ISO 13485 audit is in progress; we already work with medical OEMs under their quality systems and welcome customer audits.
Titanium Grade 2 and Grade 5 (Ti-6Al-4V), Stainless Steel 316L and 17-4 PH, PEEK, POM, and PTFE. All material comes with mill certificates traceable to heat number. Implant-grade titanium is supplied with ASTM F136 documentation when required.
Linear best ±0.005 mm, typical ±0.01 mm. Bore tolerance to H6, shaft to h5, IT5 grade. Surface roughness Ra 0.8 µm best, 1.6 µm typical. Passivation per ASTM A967 and electropolish are available for 316L stainless components.
Yes. Mutual NDA is signed before any drawing review. Files are stored on access-controlled servers, never shared with non-assigned operators, and never reused for other customers. Non-compete clauses are accepted.
Prototype 1–10 pieces typically ship in 2–3 weeks including FAI report. Small batches of 10–500 pieces run 3–5 weeks. We respond to RFQs within 24 business hours and provide DFM feedback during quoting at no charge.
Upload STEP / PDF / DWG. NDA before review on request. The factory team will respond with itemized pricing, lead time and DFM feedback.
This domain is reserved for ONE exclusive partner factory. We bring qualified international medical-device buyers; you bring the production capability and quality system.