Industry · Industry Solutions
Medical Device Manufacturing
Medical Device Manufacturing — Precision injection molding, CNC, and 3D printing under ISO 13485, covering the full chain of surgical instruments, implant prototypes, diagnostic equipment, and consumables.
Industry Requirements
Core constraints for medical part suppliers: biocompatibility (ISO 10993 testing passed), sterilizability (autoclave / EtO / gamma radiation resistant), batch consistency (100% CMM inspection per batch), traceability (DHR record chain), and zero tolerance for contamination (10K / 100K cleanroom assembly). We operate under ISO 13485, and all medical orders can follow the complete DHF / DMR / DHR documentation chain.
Typical Machined Parts
- Surgical Instruments: Handle structures, joints, clamps, retractors, scissors
- Implant Prototypes: Orthopedic plates / screws / guides (titanium Ti-6Al-4V, prototypes and pre-surgical planning only)
- Diagnostic Equipment: Analyzer housings, reagent cartridge structures, microscope components, ultrasound probe shells
- Consumables: Syringe structural parts, infusion accessories, blood collection tube holders, medical catheter connectors
- Home Healthcare: Oxygen concentrator housings, nebulizer structures, blood pressure monitor components, CPAP mask assemblies
Common Materials
- Medical PC (transparent, sterilizable) / Medical PEEK (high-temperature sterilization, implant-grade)
- Medical PP / PE (disposable instruments, consumables)
- POM / PMMA / ABS (with USP Class VI certified batches)
- Medical silicone LSR (catheters / seals / soft functional parts)
- Titanium Ti-6Al-4V Grade 23 ELI / 316L stainless steel (metal instruments and prototypes)
Certifications & Processes
- ISO 13485:2016 Quality System
- FDA 21 CFR Part 820 Process Compliance Support
- USP Class VI / ISO 10993 Biocompatibility Certified Materials
- 10K / 100K Cleanroom Assembly (per order requirements)
- Full DHF / DMR / DHR Documentation Chain Archived
- NDA + Dual Physical Isolation Development, IP Protection in Place