Surgical instruments, orthopedic implants, dental components, diagnostic housings, and endoscopic parts. 316L, Ti-6Al-4V ELI, PEEK Optima, CoCrMo. 3/4/5-axis milling and turning. Free DFM review, CMM inspection, full material traceability.
Medical device machining isn't just about tight tolerances. It's about material traceability, surface finish validation, burr-free edges on every part, documentation that survives an FDA audit, and a supplier who understands that a 0.1mm deviation in a surgical instrument isn't a cosmetic issue — it's a patient safety issue.
Material certs, CMM reports, surface finish data, and lot traceability — organized the way your regulatory team needs them. We've supported 510(k) submissions with complete device history records for machined components.
316L implant-grade stainless, Ti-6Al-4V ELI (ASTM F136), PEEK Optima, CoCrMo (ASTM F1537). All materials sourced with full mill certs from ISO 17025 accredited labs. No unverified stock — ever.
Every medical part leaves our shop burr-free. Sharp edges are chamfered or radiused per drawing. Critical surfaces inspected under 10× magnification. Ultrasonic cleaning before packaging — no cutting fluid residue.
From single prototypes for design verification to 5,000-piece production runs — we handle the full lifecycle of medical device machining.
Forceps, clamps, retractors, bone saws, drill guides, rongeurs, scalpel handles, needle holders, trocars, and laparoscopic tool bodies. 17-4 PH and 440C stainless for autoclave durability, titanium for lightweight instruments.
Tibial trays, femoral components, acetabular cups, bone plates, intramedullary nails, pedicle screws, and custom cutting guides. 316L stainless, Ti-6Al-4V ELI, and CoCr alloys machined to implant-grade surface finish.
Abutments, healing caps, impression copings, and surgical guide sleeves. Grade 4 and Grade 5 titanium, tight thread tolerances, Ra 0.4μm or better on tissue-contact surfaces.
CT scanner gantry covers, ultrasound probe housings, X-ray collimator bodies, and MRI-compatible brackets. 6061-T6 aluminum with conductive anodize, PEEK for radiolucent components, brass for RF shielding.
Endoscope body shells, articulation knuckles, working channel inlets, light post adapters, and robotic surgery end-effector mounts. Miniature and micro-machining, thin-wall stainless and titanium, burr-free edges mandatory.
Syringe pump mechanisms, valve bodies, manifold blocks, microfluidic plates, implantable pump housings. 316L for biocompatibility, PEEK for chemical inertness, Ra 0.8μm sealing faces.
Every material we machine for medical devices comes with full mill certification and lot traceability. No exceptions.
The workhorse of medical machining. Excellent corrosion resistance from molybdenum addition, resists pitting from saline and sterilization chemicals. Low carbon variant eliminates sensitization during welding. Used for surgical instruments, implants, and fluid-contact components.
Precipitation-hardening stainless that combines high strength (up to 1,300 MPa after H900 aging) with good corrosion resistance. Used for surgical instruments that need to hold a cutting edge through hundreds of autoclave cycles — bone rasps, drill bits, osteotomes. Machines well in solution-treated condition before hardening.
High-carbon martensitic stainless. Hardens to HRC 58–60 — the hardest of the stainless family. Used for cutting instruments, bearing surfaces, and wear components. Requires careful machining parameters to avoid cracking.
The implant-grade titanium. Extra-low interstitial (ELI) oxygen, nitrogen, and iron for maximum fracture toughness and biocompatibility. Used for orthopedic and spinal implants, dental abutments, and trauma fixation. Machines like a tough stainless — rigid setup, sharp carbide, flood coolant.
Implantable-grade PEEK with verified biocompatibility. Radiolucent — does not obscure X-ray, CT, or MRI imaging. Modulus close to cortical bone (3–4 GPa) reduces stress shielding. Used for spinal cages, suture anchors, and trauma plates. Demands sharp tools, conservative speeds, and burr-free edges.
Exceptional wear resistance and high strength. Used for bearing surfaces in hip and knee implants, and dental frameworks. Difficult to machine — work-hardens rapidly, requires rigid fixturing, low speeds, and high-pressure coolant. Tool life is short; this is not a material for the lowest bidder.
In medical device manufacturing, undocumented quality is not quality. Every order ships with the documentation your regulatory team needs.
Quality management system audited annually. Material traceability from mill certificate to finished part. Certificate of Conformance on every shipment.
Coordinate Measuring Machine (CMM) with ±0.002mm accuracy. Pin gauges, thread gauges, micrometer sets, and profilometer for surface roughness. Dimensional report included with every order.
Mill test certificates (MTC / EN 10204 3.1) for every lot of raw material. Full lot traceability — we can tell you which heat of material your parts came from.
Electropolishing, passivation (ASTM A967), and anodizing (Type II / Type III) through certified partners. Ra 0.4μm achievable on critical surfaces. Visual inspection under 10× magnification.
Ultrasonic cleaning to remove cutting fluid residue. Parts individually sealed in medical-grade polyethylene. Outer packaging labeled with part number, revision, lot number, and quantity.
Standard package: CMM report, material cert, CoC, and surface finish report. Extended package available for FDA submission: full FAIR (AS9102 format), process FMEA, PPAP Level 3 documentation by request.
Upload your STEP file and 2D PDF with material spec, required surface finish, and any regulatory documentation needs. If you have a material declaration or biocompatibility requirement, include it.
We review every feature for manufacturability in the specified material. We flag features that will drive cost, suggest alternatives if a different material or geometry would improve yield, and confirm material availability with certs.
Parts machined on 3/4/5-axis CNCs with specified cutting parameters for the material. Every part gets CMM inspection. Material certs, dimensional reports, and surface finish data compiled into your documentation package.
Ultrasonic cleaning, individual part inspection, medical-grade packaging with full labeling. Express shipping worldwide. Documentation package emailed before parts ship.
We hold ISO 9001:2015 certification. Our quality system, documentation practices, and material traceability align with ISO 13485 requirements — many of our medical device customers accept our documentation packages for their FDA submissions. If your project requires ISO 13485 specifically, let us know upfront and we can discuss qualification paths.
Standard: material mill certificates (EN 10204 3.1), full CMM dimensional report, Certificate of Conformance, and surface finish measurement data. Extended (by request): FAIR per AS9102 format, process flow documentation, control plans, and PPAP Level 3 packages. We understand what FDA 510(k) and CE marking technical files require.
Yes — these are materials we work with regularly. Ti-6Al-4V ELI (ASTM F136) requires careful cutting parameters to avoid surface contamination and alpha-case formation. PEEK medical grades (Optima, Zeniva) require dedicated tooling and coolant strategies to prevent annealing and maintain biocompatibility. We source all implant-grade materials from certified mills with full documentation.
As-machined: Ra 0.8μm standard, Ra 0.4μm achievable on critical surfaces. Post-processing through certified partners: electropolishing (stainless — removes surface iron, improves corrosion resistance), passivation per ASTM A967, anodizing Type II and Type III (aluminum), and PEEK annealing for crystallinity control. We never use bead blasting on implant-contact surfaces unless specified and validated.
One piece. We regularly machine single-unit prototypes for design verification, surgical simulation, and regulatory testing. The same documentation standards apply whether you order 1 part or 1,000. Prototype turnaround is typically 5–10 days depending on material and complexity.
Every raw material lot is received with a mill test certificate and assigned a unique internal lot number. That lot number follows the material through machining, inspection, cleaning, and packaging. Your parts are labeled with material grade, heat/lot number, part number, revision, and quantity. If a material issue is ever discovered, we can trace back to the specific heat of material and identify every part produced from it.
In-depth articles on medical device CNC machining, material selection, and supplier qualification.
Complete guide to CNC machining for medical devices — surgical instruments, orthopedic implants, dental components, and diagnostic equipment housings.
Read Article →Deep dive into medical-grade materials (316L, Ti-6Al-4V ELI, PEEK Optima, CoCrMo), surface finish standards, FDA documentation, and cleanroom-ready packaging.
Read Article →Supplier evaluation framework, RFQ strategy, cost drivers, quality control, and how to avoid the five most expensive mistakes when sourcing CNC machined parts from China.
Read Article →Five real parts quoted through Xometry and three China direct manufacturers — actual prices, lead times, and a decision framework for when each path makes sense.
Read Article →Upload your STEP file. We'll review every feature for manufacturability in your specified material and return a detailed quote with documentation options — typically within 24 hours.
Send Drawing for Quote