Medical CNC Machining Services
Medical CNC machining at FIRMFG produces precision medical devices, surgical instruments, and implants in an ISO 13485:2016 certified and FDA registered facility. We machine biocompatible materials including Ti-6Al-4V, PEEK, 316L stainless steel, and cobalt-chrome to tolerances of ±0.005 mm. Full traceability, sterile packaging, and Device History Records included with every order.
Medical CNC Machining Services: ISO 13485 & FDA Compliant Precision Manufacturing
Medical CNC machining at FIRMFG delivers precision-manufactured medical devices, surgical instruments, and implants that meet the most stringent regulatory requirements in the world. Operating under an ISO 13485:2016 certified and FDA registered quality management system, we machine biocompatible materials — including titanium Ti-6Al-4V, 316L stainless steel, PEEK, cobalt-chrome, and 17-4PH — to tolerances as tight as ±0.005 mm on critical implant features. Every part is backed by full material traceability, 100% inspection on critical dimensions, and a complete Device History Record (DHR) compliant with FDA 21 CFR Part 820.
Medical device manufacturing demands a fundamentally different level of control than general CNC machining. Every material lot must be certified to ASTM standards (F136 for titanium, F138 for 316L SS, F2026 for PEEK). Every machining process must be validated and locked. Every critical feature must be 100% inspected — not sampled. And every part must carry forward a documentation chain that traces it from raw material mill certificate through machining records, inspection reports, surface treatment validation, and sterile packaging. FIRMFG's ISO 13485 system enforces these requirements on every medical order, whether it is a single prototype or a 10,000-unit production run.
Our medical machining capabilities span the full spectrum of medical device manufacturing: bone screws and orthopedic implants with precision multi-start threading, surgical instruments with controlled edge sharpness and hinge tolerances, dental implants with internal conical connections held to ±0.005 mm, spinal cages in radiolucent PEEK, endoscope components with bore concentricity to ±0.005 mm, and micro medical parts with feature sizes down to 0.05 mm. We operate 5-axis machining centers, Swiss-type lathes, and micro machining equipment with spindles up to 150,000 RPM — all in a temperature-controlled environment with ISO 9001 and ISO 13485 certified quality systems.
This guide covers everything you need to know about medical CNC machining — capabilities, biocompatible materials, quality systems, tolerances, surface finishing, sterilization, and the order process. Use it as a reference when designing your next medical component, or skip ahead and request a quote for an immediate price, lead time, and DFM review.
Quick Specs: Medical CNC Machining
FIRMFG's medical CNC machining capabilities and quality certifications. These specifications apply to all medical device, surgical instrument, and implant orders.
Medical Machining Capabilities
| Capability | Specification |
|---|---|
| Tightest Tolerance | ±0.005 mm (±5 µm) |
| Standard Tolerance | ±0.01 mm (±10 µm) |
| Surface Finish (Best) | Ra 0.2 µm (mirror polish) |
| Surface Finish (Standard) | Ra 0.4 – 0.8 µm |
| Max Part Size | 600 × 400 × 400 mm |
| Machining Axes | 3 / 4 / 5-Axis simultaneous |
| Min Feature Size | 0.05 mm (50 µm) |
| Min Hole Diameter | 0.10 mm (micro drilling) |
| Max Spindle Speed | 150,000 RPM |
| Quality Standard | ISO 13485:2016 Certified |
Quality Certifications & Compliance
| Certification | Scope | Status |
|---|---|---|
| ISO 13485:2016 | Medical Device Quality Management System | Certified |
| FDA Registered Facility | 21 CFR Part 820 — Quality System Regulation | Registered |
| ISO 9001:2015 | Quality Management System | Certified |
| ISO 10993 | Biological Evaluation of Medical Devices | Compliant Materials |
ISO 13485:2016 certification covers the full medical device quality management system including design controls, risk management (ISO 14971), process validation, and traceability. FDA registration complies with 21 CFR Part 820 Quality System Regulation.
Medical CNC Machining Capabilities
FIRMFG machines the full range of medical device components — from bone screws and surgical instruments to dental implants and micro medical parts. Each capability is backed by validated processes, biocompatible materials, and ISO 13485 documentation.
Bone Screws & Implants
Precision machining of orthopedic bone screws, spinal fixation screws, and trauma implants in titanium and stainless steel. Multi-start threading, self-tapping flutes, and low-profile screw heads machined to ±0.005 mm on critical thread dimensions. Surface finishes down to Ra 0.2 µm to minimize tissue adhesion and prevent bacterial colonization.
Precision Requirements
Thread pitch ±0.005 mm · Ra 0.2 µm · 5-axis threading
Surgical Instruments
CNC machining of forceps, retractors, scissors, clamps, and handle assemblies in 17-4PH and 420 stainless steel. Edge sharpness controlled to ±0.01 mm on cutting features; hinge tolerances held to ±0.01 mm for smooth articulation without play. Passivation per ASTM A967 and electropolishing available for corrosion resistance and cleanability.
Precision Requirements
Edge ±0.01 mm · Hinge ±0.01 mm · Passivated ASTM A967
Dental Components
Dental implants, abutments, and prosthetic frameworks machined from titanium Grade 5 and cobalt-chrome. Internal hex and conical connections held to ±0.005 mm for precise implant-abutment fit. Micro-threading on collar regions and surface texturing for osseointegration achieved via 5-axis machining.
Precision Requirements
Connection ±0.005 mm · Micro threads · Ra 0.4 µm
Orthopedic Devices
Spinal cages, hip stems, knee components, and fracture fixation plates machined from titanium, cobalt-chrome, and PEEK. Complex anatomical geometries produced via simultaneous 5-axis machining. Porous surface structures for bone ingrowth machined with controlled pore size (200–800 µm) and interconnectivity.
Precision Requirements
5-axis anatomical · Pore 200–800 µm · ±0.01 mm
Endoscope Parts
Machined components for rigid and flexible endoscopes including lens housings, light post adapters, working channel tubes, and biopsy valve bodies. Bore concentricity held to ±0.005 mm for optical alignment; micro bores down to 0.5 mm with surface finish Ra 0.2 µm for smooth instrument passage.
Precision Requirements
Concentricity ±0.005 mm · Bore 0.5 mm · Ra 0.2 µm
Micro Medical Parts
Micromachining of catheter components, micro valves, stent delivery system parts, and cochlear implant features. Minimum feature size 0.05 mm, minimum hole diameter 0.10 mm, and tolerances to ±0.002 mm on micro features. High-speed spindles (150,000 RPM) and nanometer-class resolution enable medical micro manufacturing impossible on conventional CNC.
Precision Requirements
Feature 0.05 mm · Hole 0.10 mm · ±0.002 mm
Biocompatible Materials We Machine
Material selection for medical CNC machining is governed by ISO 10993 biocompatibility standards and ASTM material specifications. FIRMFG machines the eight primary implantable and medical-grade materials below, each with full mill certifications.
Titanium Ti-6Al-4V (Grade 5)
ISO 10993 compliant · Long-term implantable
Ti-6Al-4V is the gold standard for load-bearing orthopedic implants. Its strength-to-weight ratio, corrosion resistance, and biocompatibility make it ideal for permanent implants. Machinability is challenging due to low thermal conductivity and chemical reactivity with tool materials — requiring sharp carbide tooling, high-pressure coolant, and low cutting speeds.
Mechanical Properties
Tensile 950 MPa · Density 4.43 g/cm³ · Elastic modulus 114 GPa · Excellent osseointegration
Typical Medical Applications
Bone screws, spinal cages, hip stems, dental implants, fracture plates, pacemaker cases
316L Stainless Steel
ISO 10993 compliant · Short to long-term implantable
316L is the most common stainless for medical applications. The low carbon content prevents sensitization during welding and heat treatment, preserving corrosion resistance in the heat-affected zone. It meets ASTM F138 for surgical implant applications and ASTM F139 for flat-rolled implant stock.
Mechanical Properties
Tensile 580 MPa · Low carbon (0.03% max) · 2–3% Mo for chloride resistance · Non-magnetic
Typical Medical Applications
Surgical instruments, orthopedic wires, cardiovascular stents, bone plates, dental wires
PEEK
ISO 10993 compliant · Long-term implantable (ASTM F2026)
Medical-grade PEEK (ASTM F2026) is radiolucent — it does not interfere with X-ray, CT, or MRI imaging. Its elastic modulus (3–4 GPa) closely matches cortical bone, reducing stress shielding that can cause bone resorption around metallic implants. Excellent chemical resistance and steam sterilization compatibility (134°C autoclave).
Mechanical Properties
Tensile 100 MPa · Density 1.32 g/cm³ · Radiolucent · Elastic modulus close to cortical bone
Typical Medical Applications
Spinal cages, cranial implants, dental abutments, orthopedic spacers, trauma plates
Cobalt-Chrome (CoCrMo)
ISO 10993 compliant · Long-term implantable (ASTM F1537)
CoCrMo (ASTM F1537) offers the highest wear resistance of any implantable metal, making it the material of choice for articulating joint surfaces in total hip and knee replacements. Machining is extremely difficult — work hardening and high hardness require carbide tooling, low speeds, and rigid setups. Often finished by grinding or superfinishing for bearing surfaces.
Mechanical Properties
Tensile 1,300 MPa · Hardness 35–45 HRC · Exceptional wear resistance · Biocompatible
Typical Medical Applications
Knee femoral components, hip ball heads, dental frameworks, spinal disc replacements
17-4PH Stainless Steel
ISO 10993 compliant · Short-term contact (surgical instruments)
17-4PH is the preferred material for hardened surgical instruments. Machined in the solution-annealed condition (Condition A), then precipitation hardened to H1025 or H900 for final strength and edge retention. Provides excellent combination of strength, hardness, and corrosion resistance for reusable surgical tools that undergo repeated autoclave sterilization.
Mechanical Properties
Tensile 1,070 MPa (H1025) · Heat-treatable to 40+ HRC · Good corrosion resistance
Typical Medical Applications
Surgical forceps, needle holders, retractors, orthopedic drill guides, biopsy instruments
UHMW-PE
ISO 10993 compliant · Long-term implantable (ASTM F648)
Ultra-high-molecular-weight polyethylene (ASTM F648) is the standard bearing material for total joint arthroplasty. Its exceptionally low friction coefficient against CoCrMo or ceramic counterfaces makes it ideal for articulating surfaces. Medical-grade UHMW-PE is cross-linked for enhanced wear resistance and gamma-sterilized in inert atmosphere packaging.
Mechanical Properties
Tensile 40 MPa · Extremely low friction · Outstanding wear resistance · Impact resistant
Typical Medical Applications
Knee tibial inserts, hip acetabular liners, bearing surfaces for joint replacements
Nitinol (Shape Memory)
ISO 10993 compliant · Long-term implantable (ASTM F2063)
Nitinol (NiTi, ASTM F2063) exhibits superelasticity — it can undergo up to 8% strain and fully recover its shape, making it ideal for self-expanding cardiovascular stents and flexible guidewires. Machining is extremely challenging due to work hardening, tool adhesion, and shape-memory effects during cutting. Requires specialized EDM and grinding processes for most features.
Mechanical Properties
Superelastic · Austenite finish 0–20°C · Recoverable strain up to 8% · Kink resistant
Typical Medical Applications
Self-expanding stents, orthodontic wires, guidewires, orthopedic staples, heart valve frames
PEEK-CF (Carbon Fiber)
ISO 10993 testing · Load-bearing implant applications
Carbon-fiber-reinforced PEEK combines the radiolucency and biocompatibility of PEEK with significantly higher stiffness and strength. The 18 GPa elastic modulus bridges the gap between PEEK and cortical bone, making it ideal for load-bearing spinal implants. Carbon fiber content requires carbide or diamond tooling to manage abrasive wear during machining.
Mechanical Properties
Tensile 210 MPa · 30% carbon fiber reinforced · Stiffness 18 GPa · Radiolucent
Typical Medical Applications
Reinforced spinal cages, trauma plates, dental frameworks, orthopedic bracing components
Quality System & Compliance
Medical CNC machining requires a quality management system that goes far beyond ISO 9001. FIRMFG operates under ISO 13485:2016 and FDA 21 CFR Part 820, with full traceability from raw material to sterile-packaged delivery.
ISO 13485:2016 Process Overview
Our ISO 13485 quality system governs every aspect of medical part production. Design controls validate that the manufacturing process can reliably produce parts meeting specifications. Risk management per ISO 14971 identifies and mitigates manufacturing risks — from material contamination to tool wear-induced dimensional drift. Process validation (IQ/OQ/PQ) confirms that each machining operation is qualified and reproducible before production begins.
Critical processes — including machining of implant threads, surface finishing, and sterilization — are validated rather than merely verified. This means we prove the process consistently produces conforming parts, not just inspect the output. Validation records are maintained for the device's expected lifetime plus one year, per FDA retention requirements.
FDA 21 CFR Part 820 Compliance
As an FDA-registered facility, FIRMFG complies with 21 CFR Part 820 — the Quality System Regulation (QSR) for medical devices. This regulation requires document controls, design controls, purchasing controls, identification and traceability, production and process controls, acceptance activities, nonconforming product controls, CAPA (Corrective and Preventive Action), and handling of complaints.
Every medical order is processed through our controlled document system, with approved drawings, work instructions, and inspection plans. Nonconforming parts are quarantined and dispositioned through a documented material review process. CAPA investigations are initiated for any recurring nonconformance to drive root-cause elimination.
Traceability System
Full traceability is the backbone of medical device manufacturing. Every part FIRMFG produces carries a four-link documentation chain that enables forward and backward traceability from raw material to delivered, sterile-packaged component:
Material Certificate
Mill certification with heat number, chemistry, and mechanical properties per ASTM (F136, F138, F2026, F1537). Linked to incoming material lot.
Machining Record
Process parameters, machine ID, operator, tool changes, and in-process inspection data for every operation in the routing.
Inspection Report
CMM, optical, and surface measurement results. 100% verification on critical features for implantable parts; statistical sampling for non-critical.
Sterilization & Packaging
Sterilization method, cycle parameters, cleanroom packaging, and UDI labeling. Compiled into the final DHR per 21 CFR Part 820.
Device History Record (DHR)
The Device History Record (DHR) is the master document that proves a medical part was manufactured in accordance with the Device Master Record (DMR) and all applicable requirements. Per FDA 21 CFR Part 820.184, the DHR must include: (1) dates of manufacture; (2) quantity manufactured; (3) quantity released for distribution; (4) acceptance records demonstrating conformance to the DMR; (5) primary identification label and labeling used for each production unit; and (6) any device identification and control numbers used. FIRMFG compiles a complete DHR for every medical order, delivered digitally with the parts and retained for the device's expected lifetime plus one year.
Tight Tolerances for Medical Parts
Medical devices demand tolerances measured in single-digit micrometers. Implant threads, surgical edges, and micro features each have specific precision requirements that FIRMFG achieves through validated processes and 100% inspection.
| Feature | Standard (±) | Precision (±) | Ultra-Precision (±) |
|---|---|---|---|
| Bone Screw Thread Pitch | ±0.025 mm | ±0.010 mm | ±0.005 mm |
| Implant Surface (Cylindrical) | ±0.020 mm | ±0.008 mm | ±0.003 mm |
| Surgical Edge Sharpness | ±0.030 mm | ±0.010 mm | ±0.005 mm |
| Micro Feature (Hole/Slot) | ±0.015 mm | ±0.005 mm | ±0.002 mm |
| Dental Implant Connection | ±0.015 mm | ±0.005 mm | ±0.003 mm |
| Bore Concentricity | ±0.020 mm | ±0.008 mm | ±0.003 mm |
| Implant Profile (5-axis) | ±0.025 mm | ±0.010 mm | ±0.005 mm |
| Positional Accuracy | ±0.025 mm | ±0.010 mm | ±0.005 mm |
Standard tolerances apply to non-critical features and general medical components. Precision tolerances are standard for implantable parts and surgical instruments. Ultra-precision tolerances require specialized tooling, temperature-controlled machining (±0.5°C), and extended cycle times — typically reserved for micro medical parts and bearing surfaces.
Inspection Methods
Medical parts require metrology equipment matched to the precision level of each feature. FIRMFG uses a multi-method inspection strategy combining tactile CMM, optical measurement, and surface profilometry to verify every critical dimension:
CMM (Coordinate Measuring Machine)
Tactile CMM with sub-micron probes verifies dimensional accuracy on implant threads, surgical instrument hinges, and dental connections to ±0.003 mm. All critical features are 100% inspected for implantable parts. CMM data feeds directly into the Device History Record (DHR).
Optical Measurement System
Non-contact optical measurement with 0.1 µm resolution for micro features, thin walls, and delicate geometries that cannot withstand tactile probing. Video CMM and laser scanning verify micro hole diameters, bone screw thread profiles, and edge sharpness on surgical instruments.
Surface Roughness Tester
Contact and optical profilometers measure Ra, Rz, and Rt surface parameters per ISO 4287. Implant surfaces are verified to Ra 0.2 µm or better; bearing surfaces on joint replacements require Ra 0.05 µm after superfinishing. Every implant lot includes surface roughness certification.
Optical Comparator & Vision System
Profile projection and vision-based measurement for rapid first-article inspection of bone screw threads, dental implant geometries, and micro features. Provides 50–100× magnification for visual verification of thread form, edge quality, and burr absence on medical components.
Surface Finishing for Medical Parts
Surface finishing on medical parts is not cosmetic — it is functional. Electropolishing removes micro-burrs that could harbor bacteria, passivation ensures corrosion resistance in the body, and controlled surface roughness promotes osseointegration on titanium implants. All finishes comply with applicable ASTM standards.
| Process | Ra Value | Application | Standard |
|---|---|---|---|
| Electropolishing | Ra 0.1 – 0.3 µm | Surgical instruments, implants — removes micro-burrs, smooths surface, enhances passivation | ASTM B912 |
| Passivation | As-machined | All stainless steel parts — removes free iron, forms chromium oxide layer for corrosion resistance | ASTM A967 / AMS 2700 |
| Anodizing Type III (Hardcoat) | As-machined + coating | Titanium implants — increases surface hardness, wear resistance, and provides porous layer for bone ingrowth | AMS 2488 |
| Mirror Polishing | Ra 0.05 µm | Bearing surfaces for joint replacements, dental abutments, reflective optical surfaces | Custom spec |
| Bead Blasting | Ra 0.8 – 1.6 µm | Implant surface texturing — uniform matte finish promotes osseointegration on titanium surfaces | Custom spec |
| TiN / TiCN PVD Coating | As-machined + coating | Surgical instruments — gold wear-resistant coating extends tool life and edge retention | Custom spec |
Electropolishing complies with ASTM B912 and ASTM F86(for surgical implants). Passivation complies with ASTM A967 (Nitric and Citric methods) and AMS 2700. Anodizing Type III for titanium complies with AMS 2488. All surface treatments are validated processes under ISO 13485, with process records included in the DHR.
Sterile Packaging Options
FIRMFG offers full sterile packaging services in an ISO Class 7 cleanroom environment. Medical parts are double-bagged in Tyvek pouches with inner and outer sterilization barriers. Sterilization options include Ethylene Oxide (EtO) and gamma irradiation, both validated to a Sterility Assurance Level (SAL) of 10⁻⁶. Each package is labeled with lot number, sterilization date, expiration date, and UDI per FDA requirements. Custom tray configurations are available for surgical instrument sets and multi-component implant systems.
Choosing the Right Finish
For implantable titanium parts, anodizing Type III (AMS 2488) provides surface hardness and a porous layer for bone ingrowth. For surgical instruments, electropolishing (ASTM B912) after passivation (ASTM A967) delivers maximum cleanability and corrosion resistance after repeated autoclave cycles. For joint replacement bearing surfaces, mirror polishing to Ra 0.05 µm minimizes wear. For spinal cages in PEEK, bead blasting creates a uniform surface texture that promotes osseointegration. FIRMFG engineers recommend the optimal finish based on your part's function and regulatory classification.
Medical CNC Machining Examples
Representative medical parts machined at FIRMFG, illustrating the range of geometries, materials, tolerances, and applications we handle under ISO 13485 quality controls.
Cortical Bone Screw
Self-tapping cortical bone screw with 3.5 mm major diameter, 1.0 mm pitch, and multi-start thread form. Machined on Swiss-type CNC lathe with thread whirling for burr-free threads. Passivated per ASTM F86 and electropolished to Ra 0.2 µm. Full DHR includes material certificate (ASTM F136), machining record, and 100% thread inspection.
Lumbar Spinal Cage
Radiolucent PEEK spinal cage with anatomical lordotic curve, integrated fixation tabs, and micro-textured surface for bone ingrowth. Machined via 5-axis simultaneous milling with diamond tooling to minimize burr formation. Surface textured with 300 µm pore structure. Sterile-packaged in Tyvek pouches with EtO sterilization.
Surgical Forceps
Box-lock surgical forceps machined in solution-annealed 17-4PH, then precipitation hardened to H1025 (38 HRC) for edge retention and spring properties. Serrations on jaw tips held to ±0.02 mm for secure tissue grasping. Electropolished per ASTM B912 to Ra 0.2 µm for cleanability and corrosion resistance after repeated autoclave cycles.
Dental Implant Abutment
Custom dental abutment with internal conical connection (11° taper) and anti-rotation hex. Machined on 5-axis CNC with in-process measurement to ensure ±0.005 mm on the connection interface — critical for preventing micro-gap and bacterial leakage. Anodized Type III per AMS 2488 for surface hardness and osseointegration.
Medical CNC Machining Order Process
Every medical CNC machining order at FIRMFG follows a six-step process designed to ensure quality, traceability, and compliance with ISO 13485 and FDA 21 CFR Part 820. From DFM review to sterile-packaged delivery, each step is documented in the Device History Record.
DFM Review
Our biomedical engineers review your CAD model for manufacturability, verify material biocompatibility per ISO 10993, identify tolerance-critical features, and recommend process optimization. Output includes a DFM report with risk assessment and recommendations.
Material Sourcing
Biocompatible materials sourced with full mill certifications — ASTM F136 (titanium), ASTM F138 (316L SS), ASTM F2026 (PEEK), ASTM F1537 (CoCrMo). Material certificates linked to lot numbers for full traceability in the DHR.
CNC Machining
Parts machined on ISO 13485 controlled equipment — 5-axis milling, Swiss turning, micro machining. Process parameters validated and locked. In-process inspection at each operation. Temperature-controlled environment for precision features.
Inspection
100% inspection on critical dimensions using CMM, optical measurement, and surface roughness testing. First Article Inspection (FAI) per AS9102 format. All inspection data recorded in the Device History Record with operator and equipment identification.
Surface Treatment
Passivation (ASTM A967), electropolishing (ASTM B912), anodizing Type III (AMS 2488), or mirror polishing applied per specification. Surface treatments validated for biocompatibility. Process verification recorded in DHR.
Packaging & Shipping
Cleanroom packaging in medical-grade Tyvek pouches, double-bagged with ISO Class 7 cleanroom protocol. EtO or gamma sterilization available. Lot number, sterilization date, and expiration date labeled per FDA UDI requirements.
Lead Times
| Service Tier | Prototype | Production (100 units) | Notes |
|---|---|---|---|
| Standard | 7–10 business days | 3–4 weeks (100 units) | Full DHR documentation, standard inspection, passivation included |
| Rush | 3–5 business days | 2 weeks (100 units) | Expedited scheduling, same DHR requirements, 25% rush surcharge |
| Emergency | 24–48 hours | 5–7 business days | Dedicated capacity allocation, priority inspection, 50% emergency surcharge |
Lead times include DFM review, material sourcing, CNC machining, inspection, surface treatment, and packaging. Sterile packaging and sterilization add 2–3 business days. All medical orders include full DHR documentation regardless of service tier.
Medical CNC Machining FAQ
Answers to the most common questions about medical CNC machining services at FIRMFG, including ISO 13485 certification, biocompatible materials, tolerances, traceability, and sterile packaging.
QWhat is medical CNC machining?
Medical CNC machining is the precision subtractive manufacturing of medical devices, surgical instruments, and implants using computer-controlled machine tools in an ISO 13485 certified quality environment. It encompasses 5-axis milling, Swiss-type turning, micro machining, and wire EDM to produce parts from biocompatible materials such as titanium Ti-6Al-4V, 316L stainless steel, PEEK, and cobalt-chrome. Unlike general CNC machining, medical CNC machining requires full material traceability, Device History Records (DHR), FDA 21 CFR Part 820 compliance, and sterile packaging — ensuring every part meets the stringent quality and documentation requirements of the medical device industry.
QIs FIRMFG ISO 13485 certified for medical CNC machining?
Yes. FIRMFG operates an ISO 13485:2016 certified quality management system for medical device manufacturing. Our facility is FDA registered and complies with 21 CFR Part 820 (Quality System Regulation). Every medical part we produce includes full material certificates (ASTM F136 for titanium, ASTM F138 for 316L SS, ASTM F2026 for PEEK), machining process records, 100% inspection on critical features, and a complete Device History Record (DHR). Our ISO 13485 certification covers design controls, risk management per ISO 14971, process validation, and traceability — the full quality system required for medical device components.
QWhat biocompatible materials can you machine for medical parts?
FIRMFG machines the full range of implantable and medical-grade materials: Titanium Ti-6Al-4V (Grade 5, ASTM F136) for orthopedic implants and dental components; 316L stainless steel (ASTM F138) for surgical instruments and temporary implants; PEEK (ASTM F2026) for spinal cages and radiolucent implants; Cobalt-Chrome CoCrMo (ASTM F1537) for joint replacement bearing surfaces; 17-4PH stainless steel for hardened surgical instruments; UHMW-PE (ASTM F648) for joint bearing surfaces; Nitinol (ASTM F2063) for self-expanding stents; and carbon-fiber-reinforced PEEK for high-stiffness load-bearing implants. All materials are sourced with mill certifications and verified to ISO 10993 biocompatibility standards.
QWhat tolerances can you achieve for medical CNC machined parts?
FIRMFG offers three tolerance grades for medical CNC machining: Standard at ±0.01 mm (±10 µm) for non-critical features, Precision at ±0.005 mm (±5 µm) for implant threads and mating surfaces, and Ultra-Precision at ±0.002 mm (±2 µm) for micro medical features and optical surfaces. Surface finishes range from Ra 0.8 µm (as-machined) to Ra 0.05 µm (mirror polished). All tolerances are verified using CMM (±0.003 mm accuracy), optical measurement (0.1 µm resolution), and surface roughness testing per ISO 4287. Implantable parts receive 100% inspection on critical dimensions, with results documented in the DHR.
QHow do you ensure traceability for medical CNC machined parts?
FIRMFG maintains full traceability for every medical part through a four-link chain: (1) Material Certificate — mill certification with heat number, chemistry, and mechanical properties linked to incoming material lot; (2) Machining Record — process parameters, machine ID, operator, tool changes, and in-process inspection data for each operation; (3) Inspection Report — CMM, optical, and surface measurement results with 100% verification on critical features; (4) Sterilization & Packaging — sterilization method, cycle parameters, cleanroom packaging, and UDI labeling. All records are compiled into the Device History Record (DHR) per FDA 21 CFR Part 820 and ISO 13485 requirements, enabling full forward and backward traceability from raw material to delivered part.
QDo you provide sterile packaging for medical CNC parts?
Yes. FIRMFG offers cleanroom packaging and sterilization services for medical CNC machined parts. Parts are packaged in ISO Class 7 cleanroom conditions using medical-grade Tyvek pouches, double-bagged with inner and outer sterilization barriers. Sterilization options include Ethylene Oxide (EtO) sterilization and gamma irradiation, both validated to SAL 10⁻⁶ (Sterility Assurance Level). Each package is labeled with lot number, sterilization date, expiration date, and UDI (Unique Device Identifier) per FDA requirements. Custom packaging configurations, including tray kits with multiple components, are available for surgical instrument sets and implant systems.
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Micro CNC machining for medical micro parts with feature sizes down to 0.05 mm and tolerances to ±2 µm. Micro milling, micro turning, and micro drilling for catheter components, micro valves, and cochlear implants.
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Full-range CNC milling, turning, and 5-axis machining across 50+ materials. From prototype to production with ISO 9001 and ISO 13485 certified quality systems.
Learn MoreCNC Machining Stainless Steel
Precision machining of 316L, 17-4PH, and 420 stainless steel for surgical instruments and medical devices. Passivation per ASTM A967 and electropolishing per ASTM B912.
Learn MoreStart Your Medical CNC Project
Upload your CAD files and get a free medical CNC machining quote within 24 hours. Our biomedical engineers provide DFM feedback, material recommendations per ISO 10993, and process validation support at no cost. ISO 13485 certified quality, FDA registered facility, tolerances to ±0.005 mm, sterile packaging, and full Device History Records with every order. From single prototypes to production volumes, FIRMFG is your medical machining partner.