Falcon Machining Services is at the forefront of ISO 13485-certified medical component manufacturing, delivering precision-critical parts for surgical tools, implants, and diagnostic devices. Leveraging 5-axis CNC technology and biocompatible materials like titanium, PEEK, and stainless steel, we ensure compliance with FDA and ASTM standards while meeting the medical industry’s demand for micron-level accuracy (±0.002 mm).
Why CNC Machining is Critical for Medical Device Manufacturing
CNC machining is the gold standard for medical applications due to its unmatched precision, repeatability, and versatility. Key advantages include:
Sub-micron Tolerances: Achieve ±0.002 mm accuracy for implants and micro-surgical tools.
Material Flexibility: Machine biocompatible metals (titanium, stainless steel) and plastics (PEEK, Delrin).
Sterilization Compliance: Components withstand autoclaving (121°C, 15 PSI) without degradation.
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ISO 13485 Certified | 10-Day Prototyping | Bulk Discounts
Material Selection Guide for Medical Components
Choosing the right material is critical for functionality and regulatory compliance:
| Material | Application | Key Properties |
| Titanium Gr5 | Implants, bone plates | Biocompatible, 950 MPa tensile strength |
| PEEK | Surgical instrument handles | Radiolucent, chemical resistance |
| 316L SS | Diagnostic equipment components | Passivated surfaces (Ra 0.4µm) |
Titanium Machining: Cryogenic cooling reduces tool wear by 25% during deep-hole drilling.
PEEK Finishing: Laser etching ensures traceability per UDI regulations.
Case Study: High-Volume Surgical Forceps Production
Client: Global Surgical Equipment Manufacturer
Challenge: Manual polishing of 316L stainless steel forceps caused inconsistent surface finishes (Ra 0.8–1.6µm).
Solution:
Automated CNC Polishing: Achieved uniform Ra 0.4µm finish across 50,000 units.
Laser Marking: Added permanent UDI codes without compromising sterility.
Results:
20% Faster Production: Reduced cycle time from 8 to 6.5 minutes per unit.
Zero FDA Non-Compliance: Passed 100% inspection under ISO 13485 audits.
