Medical Device Manufacturing: ISO 13485 & Biocompatible Materials
Precision components for surgical instruments, diagnostic instrumentation and medical device assemblies, manufactured under ISO 13485 aligned controls with the material evidence and process documentation regulated buyers require.
- ISO 13485 aligned
- Biocompatible alloys & resins
- Clean-room compatible handling
- EN 10204 3.1 material certs
- Validated cleaning processes
Program types we support
Parts supplied by Unity Manufacture are non-implant, non-life-supporting components. Final regulatory classification of the finished device remains the responsibility of the manufacturer.
Typical parts we manufacture for medical programs
The line between “medical” and “industrial” precision parts is thin — it is the documentation, the traceability and the cleanliness that carry the difference.
| Part type | Why we make it this way | Material families |
|---|---|---|
| Surgical instrument handles and shafts | Stainless or titanium with high-polish surfaces and tight concentricity between mating parts | 316L stainless, Ti-6Al-4V ELI |
| Diagnostic analyser chassis | CNC machined enclosures and brackets that hold PCBs, optics and fluidic sub-assemblies in place | 6061-T6 (anodized), 316L, PEEK |
| Lab automation components | High precision parts for repeatable liquid handling and robotic positioning | 316L, anodized aluminium, PPSU |
| Plastic enclosures and sub-faces | Molded or machined polymer parts in medical-grade resins with validated colour control | Polycarbonate, ABS, PEEK, PPSU |
| Manufacturing tooling and gauges | Inspection fixtures, assembly jigs and line-side gauges for the OEM’s own production | Hard anodized aluminium, 316L |
| Sheet metal enclosures for equipment | Clean-look enclosures with reduced fastener count and integrated venting | 5052, 304 stainless |
Manufacturing route we recommend
- Swiss-style CNC turning for long thin shafts, handles and bushings where concentricity drives function.
- CNC milling for instrument bodies, analyser chassis and bracketry with multiple features.
- Wire EDM for delicate features in hardened stainless and titanium where conventional tooling is not viable.
- Plastic injection molding for production-volume enclosures, sub-faces and consumable device parts.
- Sheet metal fabrication for equipment enclosures and panels.
- Documented inspection with first article and capability data on critical characteristics.
Materials for medical programs
Material selection is both a performance and a regulatory decision. The list below covers the most common choices for the components we make — final suitability for the finished device is decided with the manufacturer.
- 316L stainless
- Ti-6Al-4V ELI titanium
- 6061-T6 anodized aluminium
- 304 stainless
- PEEK (unfilled and filled grades)
- PPSU
- Polycarbonate
- Medical-grade ABS
View our capability for titanium as used on instrument shafts and high-precision fittings.
Surface and cleaning processes
Surface finishes
- Electropolishing for stainless components
- Passivation to ASTM A967
- Hard anodize Type III for aluminium bodies
- TiN and DLC coating on wear surfaces
- Ultrasonic cleaning before packing
Documentation we provide
- Material certificates (EN 10204 3.1)
- Biocompatibility evidence on request
- First article and capability data
- USP Class VI letters where applicable
- Cleaning and packaging records
Recent project snapshot
Diagnostic analyser sub-assembly — machined, sheet and polymer
A benchtop diagnostic analyser sub-assembly combined a machined aluminium chassis, a formed sheet metal enclosure and a polycarbonate front panel. The full BOM was produced in one cell, with material traceability captured lot-by-lot and validated cleaning applied before packing.
- Process
- CNC milling + sheet metal fabrication + small-batch polymer machining
- Tolerance
- ±0.025 mm on locating features
- Documentation
- First article, material certs, cleaning record, C of C
- Outcome
- 500 assemblies delivered annually on a Kanban schedule
Frequently asked questions
Are your medical programs covered by an ISO 13485 certification?
Yes. We confirm the scope, sites and expiry during quotation. The certificate covers the production facilities and processes used for the program.
Do you manufacture finished, sterile medical devices?
No. Unity Manufacture supplies non-implant, non-life-supporting components and sub-assemblies. Sterilization and final regulatory release are handled by the device manufacturer.
What biocompatibility evidence do you supply?
Material certificates, resin grade letters and supplier-side biocompatibility summaries where available. In-vivo testing is coordinated through the device manufacturer.
Can you machine long thin parts from titanium?
Yes. Swiss-style turning and precision milling handle the long thin geometries typical of surgical shafts and dental instruments.
How do you prevent cross-contamination?
Material lots are kept separated through machining and finishing, and ultrasonic cleaning precedes packing for parts designated as cleaned before delivery.
Send the device bill of materials
Tell us the components you need, the materials you prefer, and the regulatory documentation your team requires. We will confirm scope and lead time before quoting.