의료기기89+ Cases
의료기기Precision Manufacturing
ISO13485-aligned medical-grade manufacturing with compliance traceability
Medical-grade machining with PEEK, biocompatible titanium, and 316L stainless, aligned with FDA/CE requirements. Surgical instruments, implant prototypes, diagnostic structures, and custom fixtures with full traceability.
ISO13485FDA/CEBiocompatibilityClean roomBatch traceabilityASTM F136Ra≤0.4Sterilization ready
89+
Medical projects
Ra0.4
Surface finish
10 days
Prototype lead time
Core Processing Capabilities
Medical titanium precision machining
PEEK implant prototype manufacturing
316L surgical instrument parts
Clean-room machining
Mirror polish Ra≤0.4
Biocompatible material cert management
Fluorescent penetrant inspection
Vacuum heat treatment coordination
Laser UDI marking traceability
Implant topology-optimized structures
Diagnostic housing and structures
Medical silicone molded parts
Sterilization-compatible surface treatment
First-article FAI reports
FDA 510(k) sample support
Clean packaging and labeling
Featured Cases
Orthopedics firm — Titanium implant prototype
Ra0.35
Surface finish
ELI grade
Material grade
12 days
납기
100%
Biocompat pass
Process / Material
5-axis milling + mirror polish · TC4 ELI titanium
Customer Challenge
Implant requires ASTM F136 ELI material, Ra≤0.4 surface, with biocompatibility and fatigue test specimens.
Solution
Dedicated medical cutting parameters; mirror polish; fatigue specimens same batch with MTC and chemistry reports.
Result
Biocompatibility pass, Ra 0.35, fatigue life met, 15 pcs in 12 days.
Typical Parts & Quick Quote
Orthopedic implant prototype
TitaniumELI gradeMirror finish10-14 days
¥6,800from
Surgical instrument handle
316LPassivationSterilization
¥1,980from
PEEK connector plate
PEEKBiocompatibleBur-free7-10 days
¥3,400from
IVD device housing
InjectionV-0 FRTexture
¥2,600from
Dental surgical guide
3D 프린팅H7CT aligned
¥4,500from
Rehab exoskeleton joint
6061Anodize경량화
¥2,900from
CT slip ring bracket
7075FlatnessFull inspect
¥3,600from
Needle hub
316LVMHoningEtO ready5-7 days
¥880from