CNC Machining for Medical Devices
Resolute Precision Manufacturing provides ISO 9001-certified precision CNC machining for medical device and surgical instrument manufacturers. Our Swiss CNC machines produce complex small-diameter components in stainless steel, titanium, and PEEK with the tolerances and surface finishes required for medical applications. Our medical CNC machining capabilities support prototypes through high-volume production, with direct sales, no distributor markup, 24-hour quote response, and full material traceability on every order. Request a QuoteWhy Swiss CNC is the Medical Device Machining Platform
Medical device components are among the most demanding machined parts in any industry. Implant components and surgical instruments can require tight dimensional tolerances, controlled surface finishes, and materials with specific biocompatibility characteristics. Small-diameter components such as bone screws, cannulas, trocar components, and instrument drives are common applications for medical device CNC machining.
Swiss CNC machining is well suited to this class of component. The guide bushing support system helps minimize deflection on small-diameter parts, supporting tight tolerances required for precision cnc medical parts. Multiple features including OD, ID, threads, cross-holes, and drive profiles can often be completed in a single cycle, reducing re-fixturing and setup-related variation.
Swiss machining can also produce consistent as-machined surface finishes for components where surface characteristics are important. Additional finishing processes can be coordinated when tighter surface-finish requirements apply.
Medical Materials We Machine
We machine a range of materials used in medical devices and surgical instruments, with process controls appropriate to each material:
316L stainless steel — commonly used for medical and implant applications; passivation can be coordinated to applicable customer and specification requirements.
Titanium Grade 5 (Ti-6Al-4V ELI) — high strength-to-weight ratio and corrosion resistance for demanding medical and implant applications.
Titanium Grade 2 — commercially pure titanium used where corrosion resistance and biocompatibility are important.
PEEK (polyetheretherketone) — high-performance polymer used in selected medical, implant, and instrument applications.
17-4 PH stainless steel — high-strength stainless steel for surgical instruments and other demanding components.
Delrin and UHMWPE — engineering polymers used for selected non-implant instrument components and trial applications.
Specifications at a Glance
| Swiss CNC | 20mm, 32mm, and 38mm production equipment for small-diameter medical components |
| Tolerances | ±0.0005″ routinely; tighter tolerances achievable for critical dimensions |
| Surface Finish | Ra 16–32 microinch as-machined; Ra 8 or better available with coordinated polishing |
| Materials | 316L stainless steel, titanium (Grade 2 and Grade 5 ELI), 17-4 PH stainless steel, PEEK, Delrin, and UHMWPE |
| Passivation | Coordinated per ASTM F86 and AMS 2700 for stainless steel implant components |
| Traceability | Material traceability to certified heat numbers is standard on all medical orders |
| Quality | ISO 9001:2015; first article inspection and in-process dimensional records |
| Documentation | Material certifications, process certifications, inspection records, and certificates of conformance |
| Volume | Prototype quantities through high-volume production |
Medical Device Component Types We Produce
Resolute Precision Manufacturing produces precision CNC medical parts for multiple medical device and surgical instrument applications:
Orthopedic implant fasteners — bone screws, cannulated screws, and interference screws in titanium and 316L stainless steel.
Surgical instrument components — drives, handles, jaw components, and actuator elements in 17-4 PH and 316L stainless steel.
Minimally invasive device components — trocar components, cannulas, and access-device elements.
Drug delivery device components — valve components, precision dosing elements, and tooling or molding components where applicable.
Diagnostic instrument components — precision turned and milled components for laboratory and diagnostic equipment.
Dental device components — selected implant components, abutments, and instrument elements in titanium and stainless steel.
Our medical CNC machining processes can support both simple turned components and complex Swiss-machined parts, depending on the geometry, material, tolerance, and production requirements.
Frequently Asked Questions
Q: Does RPM hold ISO 13485 certification for medical devices?
A: RPM holds ISO 9001:2015 certification. We are not currently ISO 13485 certified. We support medical device programs within our ISO 9001 framework with material traceability, first article inspection, and process documentation that satisfies most medical device supplier qualification requirements. Discuss your specific quality requirements with our team.
Q: Can RPM provide material traceability for implant-grade materials?
A: Yes. Material traceability to certified heat numbers is standard for all medical orders. We retain material certifications, certificates of compliance, and heat number records referenced to specific production lots. Implant-grade 316L and titanium ELI materials are sourced from certified suppliers with full documentation.
Q: What surface finish does RPM achieve on medical stainless components?
A: Our Swiss CNC machines produce Ra 16–32 microinch as-machined on 316L stainless. For applications requiring smoother surfaces, we coordinate electro-polishing or mechanical polishing through our outside processing network, achieving Ra 8 or better. Surface finish requirements are specified on the drawing and confirmed in first article inspection.
Q: Can RPM machine PEEK for medical device applications?
A: Yes. PEEK is a standard material in our machining program. Medical-grade PEEK (PEEK-OPTIMA or equivalent) is sourced with full material certification. Our turning and milling operations produce PEEK components to the dimensional and surface finish requirements of the drawing.