Precision Manufacturing: 5-Axis CNC Machining, Injection Molds, and Rapid Prototyping Solutions.
ISO 13485 CNC & Molding Supplier
ISO 13485 medical manufacturing means producing medical devices and components under a controlled, audit-ready quality system. At SPI, we align our CNC machining and molding workflows with ISO 13485 so your surgical instruments, implants and device housings are precise, clean and fully traceable.
From micro Swiss-type shafts and 5-axis titanium implants to injection-molded housings, we deliver burr-free edges, validated cleaning and lot-level documentation for regulated markets. Learn more about our company and certifications.
24h quotation • Free DFM review • NDA available
ISO 13485 medical manufacturing is the production of medical devices and components under a quality system that meets ISO 13485 requirements. It combines controlled machining and molding processes with documented traceability, risk management, validated cleaning and inspection, so every lot of parts is safe, repeatable and audit-ready.
See how we implement ISO 13485 in our shop.
In practice this means:
Choosing an ISO 13485 manufacturer is not just about machine types – it is about how reliably they can reproduce your print, documentation and cleanliness requirements across many lots. SPI combines multi-axis machining with a mature quality system built for regulated customers.
Integrated ISO 9001, IATF 16949 and ISO 13485 quality assurance for CNC machining and molding, with documented procedures from RFQ through shipment.
Experience with Ti-6Al-4V, 316L, Co-Cr, PEEK, PPSU and other medical-grade materials, including validated machining, finishing and cleaning workflows for implants and device components.
Dedicated metrology lab for critical-to-quality features, with CMM, optical vision systems, surface profilometers and roundness testers reserved for medical and life-science projects.
Dimensional reports, material and finish certificates, DHR and traceability packs prepared so your regulatory, supplier quality and customer audits run smoothly.
If you need to audit or qualify a new supplier, we can provide our equipment list, sample reports and a signed NDA before you share drawings.
Learn more about our team and history.
Most medical machining projects we see fall into three families: metal surgical and implant-adjacent parts, plastic housings and fixtures, and sheet/plate or pre-form workflows. Each family has its own risks – from burr control and Ra on cutting edges to positional tolerances on manifolds and cosmetic requirements on handheld housings.
Typical parts include bone screws, jaws, clamps, small shafts and instrument fixtures in Ti-6Al-4V, 316L, 17-4PH and Co-Cr alloys.
Medical housings, ergonomic handles, jigs & fixtures, pilot runs. We support quick bridge builds using CNC-machined plastics and vacuum casting, then transition to full medical injection molding once designs are frozen.
Laser-cut blanks, cast-to-machine aluminum, and precision finishing for medical devices, instruments and tooling.
Typical CNC-machined medical parts include:
For each part family, we adapt our tooling, fixturing and inspection plans to the risks: sharp edges on surgical jaws need 100% burr checks and Ra control, while bone screws and micro shafts run on Swiss-type lathes with in-process gauging to maintain concentricity and thread quality.
See anonymized medical projects we have supported in our case studies library.
Many medical devices combine metal working parts with plastic housings, fixtures and transparent covers. We routinely machine and mold PEEK, PEI, PPSU, PTFE, PC/ABS and PMMA for implant-adjacent components, reusable handles, trays and handheld device housings.
| Material | Typical use | Sterilization / chemistry | Machining / design notes |
|---|---|---|---|
| PEEK | Implantable components (per spec), structural housings | Steam / EtO / gamma tolerant | Pre-dry; allow for thermal expansion; stress-relieve after machining |
| PEI (Ultem) | High-temp fixtures, semi-transparent covers | Steam / EtO tolerant | Good stability; consider wall ≥1.5 mm for housings |
| PPSU | Reusable handles, trays | Excellent repeated steam | Tough; fillets for stress relief; good chemical resistance |
| PTFE | Low-friction seats, liners | Broad chemical tolerance | Creep / cold-flow—use larger bearing areas, avoid tight load-bearing fits |
| PC/ABS | Handheld housings, ergonomics | EtO / low-temp preferred (steam not ideal) | Impact-resistant; avoid harsh solvents; cosmetic textures acceptable |
| PMMA | Clear windows, light guides | Limited to non-repeated steam | Polishable; avoid stress-cracking—gentle cleaners only |
For early prototypes and low volumes, we CNC-machine plastics or use vacuum casting to bridge the gap before hard tooling. Once your design is frozen, we transfer to medical injection molding so you can scale production while keeping the same material and cosmetic specifications.
For more details on wall thickness, draft and gate placement, see our injection molding design guide. You can also review a real medical molding case study to see how we combine CNC, molding and finishing for regulated projects.
For most medical CNC parts, typical machining capability is ±0.01 mm on linear and hole sizes, 0.02 mm on true position and 0.8–1.6 µm Ra on machined surfaces. With optimized fixturing and inspection, validated capabilities can reach ±0.002 mm on critical features and ≤0.4 µm Ra after polishing or electropolishing.
| Feature | Typical capability | Validated capability | Notes |
|---|---|---|---|
| Linear / hole size | ±0.01 mm | ±0.002 mm | Depends on geometry, fixturing, tool reach, material stability |
| True position | ±0.02 mm | ±0.005–0.010 mm | With datums & 5-axis / fixture strategy |
| Flatness / parallelism | 0.02 mm | 0.005–0.010 mm | Plate size & clamping strategy dependent |
| Roundness / cylindricity | 0.01 mm | 0.003–0.005 mm | Validated with roundness tester / CMM |
| Surface roughness (Ra) | 0.8–1.6 µm (machined) | ≤0.4 µm (polish / electropolish) | Specify function-based RA targets |
| Threads (metric / UNF) | Go / No-Go per print | Class-specific validation | ISO metric 6H / 6g, UN / UNF 2B / 2A gauges |
| Micro features | Pins / slots ≥Ø0.5 mm | Tighter on request | Requires microscope verification |
| Wall thickness (Ti / PEEK) | ≥0.5–1.0 mm typical | Case-by-case | Account for heat, stress relief, cleanup stock |
In quotes and process planning we distinguish between typical capability and validated CTQ capability. Typical numbers are what we comfortably hold across families of parts; validated values are proven on defined critical features with full CMM reports, SPC charts and capability studies. See how we qualify CTQs in our quality assurance process.
Not sure if your drawing is realistic? Upload it for a free CNC DFM review.
Tight tolerances and long-term implants are only as good as the way they are measured. Our dedicated metrology lab supports medical parts with CMM, optical vision systems, surface profilometers, roundness testers, hardness testers and coating thickness gauges, all maintained under a documented calibration schedule.
| Instrument | Purpose | Typical range / resolution | When we use it |
|---|---|---|---|
| CMM | 3D GD&T, true position | µm-level, program-driven | FAIs, CTQs, PPAP / validation lots |
| Optical vision system | Micro-feature measurement | Sub-10 µm | Slots, micro holes, edges, plastic features |
| Surface profilometer | Ra / Rz verification | Ra down to ≤0.1 µm | Mating faces, polished / electropolished zones |
| Roundness / cylindricity tester | Form errors on shafts / bores | µm-level | Swiss-type shafts, bearing fits |
| Height gauge / granite | Datum heights, steps | 0.001 mm increments | Fast in-process checks |
| Bore gauges / pin gauges | Bore size verification | Class-fit pins | Tight bores, post-finish checks |
| Thread gauges (metric / UNF) | Go / No-Go acceptance | Class 6H / 6g; 2B / 2A | Metal & plastic threads per spec |
| Hardness tester | HRC / HB | — | Heat-treated 17-4PH, others |
| Microscope (≥40x) | Edge / burr inspection | — | Micro-deburr acceptance |
| Coating thickness (as needed) | Anodize / hardcoat checks | µm-level | Confirms buildup / penetration on Al |
For qualification runs and audits, we can align our measurement methods with your internal procedures and provide GR&R studies on the gauges used for CTQs. This ensures your supplier quality team can trust every data point in the inspection reports.
Need a deeper look at our equipment? Download our latest equipment list.
For medical parts we treat quality data as seriously as dimensions. Key characteristics (CTQs) are defined at RFQ, and then monitored with SPC charts, capability studies and regular MSA/GR&R on the gauges used. Our target is Cpk ≥ 1.67 on CTQs in steady-state production, with higher sampling during ramp-up. First article inspection reports are part of our overall quality assurance package.
| Topic | Target / practice | Notes |
|---|---|---|
| Sampling & AQL | Customer spec or internal plan | Defined at RFQ / PO; CTQs elevated |
| SPC charts | X̄–R / X̄–s on CTQs | Continuous for mass production |
| Process capability | Cpk ≥ 1.67 on CTQs | Start-up may run at 1.33 during stabilization |
| MSA / GR&R | ≤10% preferred, ≤20% acceptable | On gauges used for CTQs |
| First Article | FAI per drawing / ballooned report | PPAP / ISIR available on request |
| Gauge calibration | Scheduled cycle with records | Stickers + certificates tracked |
| Nonconformance | NCR + corrective action (8D if req.) | With customer approval for disposition |
| Cleanliness validation | Post-clean checks per SOP | Links to cleaning & packaging records |
During first articles and early production, we typically run more frequent checks and may accept Cpk around 1.33 while the process stabilizes. Once stable, CTQs move to Cpk ≥ 1.67 with ongoing SPC monitoring, while non-critical dimensions follow agreed AQL plans. You can also see how we implemented SPC and documentation controls in a real project in our medical molding case study.
Every box of parts leaves our facility with documentation designed for medical device manufacturers. At a minimum you receive material certificates, dimensional reports on CTQs and a signed packaging release note, with optional finish certificates, DHR and CoC tailored to your quality agreements and SOPs.
| Document | What it includes | Default / Optional |
|---|---|---|
| Dimensional report (CMM / Vision) | Ballooned features, CTQ results, instruments | Default for CTQs; full on request |
| Material certificate | Heat / lot traceability (e.g., EN 10204 3.1) | Default |
| Finish certificate | Passivation / electropolish / anodize parameters | As required |
| Surface finish record | Ra / Rz readings at defined zones | As required |
| Heat-treat certificate | Condition (e.g., 17-4PH H900) | As required |
| Packaging release note | Lot / serial IDs, counts, inspector sign-off | Default |
| DHR / lot traceability sheet | PO → heat lot → process cards → inspections → release | On request |
| Certificate of Conformance (CoC) | Conformance statement to print / spec | Default |
For new supplier qualifications or audits we can also prepare full DHR traceability packs that link your PO to material heats, process cards, inspection records and final release notes, so your regulatory and supplier quality teams have everything they need in one place.
For details on quotation, shipment and packaging options, see our FAQ, or jump directly to topics on quotation, shipping and packaging.
Bringing a new medical machining supplier online usually involves more than one PO. Our workflow is designed to move from NDA and RFQ to validated production with as little friction as possible, while giving your quality and sourcing teams the data they need.
Examples of CNC-machined medical parts
For most medical CNC parts we hold ±0.01 mm on linear and hole sizes, around 0.02 mm on true position and 0.8–1.6 µm Ra on machined surfaces. On defined CTQs, validated capabilities can reach about ±0.002 mm and ≤0.4 µm Ra with polishing or electropolishing.
We routinely machine Ti-6Al-4V (including ELI), Ti-6Al-7Nb, 316L, 17-4PH and Co-Cr alloys for implants and surgical tools. For housings, fixtures and trays, we support PEEK, PEI, PPSU, PTFE, PC/ABS and PMMA. If you use a different medical grade, we can review specifications and propose equivalent materials or processing options.
As standard you receive material certificates, dimensional reports on CTQs and a packaging release note. On request we add surface-finish and heat-treat certificates, DHR traceability sheets and a Certificate of Conformance aligned with your internal procedures.
For more general questions on ordering, quotation and shipping, visit our main FAQ.
Whether you are qualifying a new supplier or moving an existing program, our team can help you de-risk machining, molding and documentation under ISO 13485. Share a pilot project and we’ll come back with a clear DFM note, realistic tolerances and a transparent quotation.
Want to know more about how we work with customers worldwide? See Why Super-Ingenuity or visit our FAQ for details on orders, quotations and shipping.
