What medical device parts can you CNC machine?

We machine surgical instrument components, medical device housings, implantable device prototypes, and diagnostic equipment parts.

What materials are used for medical CNC parts?

Stainless Steel 316L, Titanium Grade 5 (Ti-6Al-4V), PEEK, UHMWPE, and Aluminum 6061 in ISO 13485 clean environments.

What tolerances can you achieve for medical components?

We hold ±0.005mm on critical medical device features, validated with Zeiss CMM and Micro-Vu optical inspection.

Do you offer surface finishing for medical parts?

Yes, electropolishing, passivation, bead blasting, and medical-grade anodizing available for all medical CNC parts.

Can you provide validation documentation?

Yes, full IQ/OQ/PQ protocols and material certifications per FDA and ISO 13485 requirements for medical device manufacturing.

Industry

Medical Device CNC Precision Machining | ISO 13485

Precision CNC machining for the medical device industry. Surgical instruments, implant trial components, diagnostic equipment parts, and medical electronics housings. Machineable stainless, titanium, PEEK, and medical-grade polymers. ISO 13485 quality system.

🔥 3-6 week lead timeStainless 316LTitanium Grade 23PEEKISO 13485CMM Report

Typical Parts We Machine

Surgical instrument components — stainless 17-4PH, passivated
Orthopedic trial instruments — titanium Grade 5, anodized
Diagnostic equipment parts — aluminum, tight-tolerance bores
Medical electronics housings — aluminum, EMI-shielded, sealed
Implant-grade trial components — PEEK, UHMWPE, biocompatible
Fluid handling fittings — stainless 316L, electropolished
Custom sterilisation trays and containers — aluminum, laser-marked
Laboratory instrument frames — aluminum, precision-machined

Materials

Stainless 304, 316L, 17-4PH; Titanium Grade 5 (Ti-6Al-4V ELI), Grade 23; PEEK (medical grade); UHMWPE; Aluminum 6061-T6. Full material traceability. Biocompatibility documentation available.

Quality

Strict process control per ISO 13485. 100% critical dimension inspection. Surface finish Ra 0.4μm or better on instrument surfaces. Cleanroom-compatible packaging available. Device history record (DHR) per part.

Standards & Certifications

ISO 13485 Quality SystemFDA QSR (21 CFR 820)Cleanroom-Compatible AssemblyMaterial TraceabilityDevice History RecordSterilisation-Compatible Packaging

Related Industries

These precision machining tracks share similar processes, materials, and quality standards.

Frequently Asked Questions

Is TruPart certified to ISO 13485?

TruPart operates under ISO 13485-compatible quality systems for medical device manufacturing. Our processes, documentation, and traceability meet medical device regulatory requirements. Contact us for specific compliance needs.

What medical-grade materials can you machine?

We machine stainless 304/316L/17-4PH, titanium Grade 5 and Grade 23 ELI, PEEK, UHMWPE, POM, and medical-grade aluminum. All materials supplied with biocompatibility certification and batch traceability.

Can you hold implant-grade tolerances?

Yes. Standard medical tolerance: ±0.05mm. For precision instruments: ±0.01mm. For critical mating surfaces: ±0.005mm. CMM verification on all critical dimensions.

What surface finishes can you achieve on surgical instruments?

Ra 0.4μm standard on instrument surfaces. Ra 0.2μm available for cutting and mating surfaces. Electropolishing, passivation, and bead blasting available. All finishes meet ASTM F86 standards.

Do you provide Device History Records?

Yes. Every medical part includes DHR with material lot traceability, in-process inspection results, final inspection report, and calibration records for all measurement equipment.

Can you machine PEEK and other medical polymers?

Yes. We have extensive experience with PEEK, UHMWPE, POM (Delrin), and medical-grade PPSU. Precision tolerances to ±0.02mm on polymer parts with burr-free edge finishing.