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Custom Machining Service for Medical Devices With ISO 13485 Standard Compliant
Product Spotlights
ISO 13485 compliant custom machining service for medical devices, offering precision tolerances down to ±0.005mm, medical-grade materials, full traceability, and fast lead times (5–15 days for prototypes). Trusted by global OEMs, with 10,000+ sqm factory and multiple quality certifications.
US$ 1000
≥1 Combo
Key Specifications
Get Latest Price
Material Options:
Stainless Steel, Titanium, Aluminum, PEEK, Medical-Grade Plastics
Machining Tolerance:
±0.005mm (standard), ±0.001mm (high precision)
Surface Finishing:
Electropolishing, Passivation, Anodizing, Bead Blasting, Medical-Grade Coating
Payment & Shipping
Payment Methods:
Port of Shipment:
qingdao|tianjin
Delivery Detail:
30 days
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Material Options
Stainless Steel, Titanium, Aluminum, PEEK, Medical-Grade Plastics
Machining Tolerance
±0.005mm (standard), ±0.001mm (high precision)
Surface Finishing
Electropolishing, Passivation, Anodizing, Bead Blasting, Medical-Grade Coating
Certification Compliance
ISO 13485, ISO 9001, HACCP, TL900, QS9000, SA8000, ISO14000, OHSAS18001
Production Capacity
10,000+ parts per month
Application Field
Surgical Instruments, Implants, Diagnostic Equipment, Dental Devices, Orthopedic Devices
Inspection Equipment
CMM, Optical Comparator, 3D Scanning, X-ray Inspection
Lead Time
5-15 working days for prototypes, 15-25 working days for mass production
Henan San Kuang Machinery Technology Co., Ltd. is a professional manufacturer specializing in custom machining services for medical devices, fully compliant with the ISO 13485 standard. Located in Luoyang, Henan, China, our factory spans 10,000–30,000 square meters and employs 51–100 skilled technicians. We deliver high-precision components for surgical instruments, implants, diagnostic equipment, and more. With annual export value exceeding US$2.5 million, we serve global markets including North America, Europe, and Southeast Asia. Our commitment to quality, traceability, and regulatory compliance makes us a trusted partner for medical device OEMs and contract manufacturers.
Our custom machining service covers a wide range of processes: CNC turning, milling, grinding, EDM, and Swiss-type machining. We work with medical-grade materials such as stainless steel (316L, 17-4PH), titanium (Grade 5, Grade 23), aluminum, PEEK, and other polymers. Each part is produced under strict quality control, with ISO 13485-compliant documentation and full traceability from raw material to final inspection.
Key Features & Technical Specifications
- Precision Tolerances: Achieve tolerances as tight as ±0.005mm for standard parts, and ±0.001mm for high-precision components. Our CMM and optical inspection equipment ensure every dimension meets your specifications.
- Surface Finishing Options: We offer electropolishing, passivation, anodizing, bead blasting, and medical-grade coatings to enhance biocompatibility, corrosion resistance, and aesthetics.
- Material Certification: All raw materials come with mill certificates and are fully traceable. We can provide 3.1 or 3.2 certificates upon request.
- Cleanroom Assembly: Optional cleanroom environment (ISO Class 7) for assembly and packaging of sterile or critical components.
- Design for Manufacturability (DFM): Our engineering team reviews your designs and offers suggestions to optimize cost, lead time, and manufacturability without compromising function.
- Lot Traceability: Each production lot is assigned a unique batch number, and all records are maintained for at least 10 years to comply with medical device regulations (FDA, MDR, etc.).
Typical Parameters (Table)
| Parameter | Standard Range | High Precision Range |
|---|---|---|
| Tolerance | ±0.05 mm | ±0.005 mm |
| Surface Roughness (Ra) | 0.8 μm | 0.2 μm |
| Max. Part Size | 500 mm x 400 mm | 200 mm x 200 mm |
| Min. Hole Diameter | 0.5 mm | 0.1 mm |
| Inspection Equipment | CMM, Optical Comparator | 3D Scanner, X-ray, Microscope |
Benefits to Your Business
- Regulatory Confidence: Our ISO 13485-compliant quality management system ensures that your products meet the strict requirements of medical device regulations (FDA 21 CFR 820, EU MDR, etc.).
- Cost Savings: By optimizing designs for manufacturability and leveraging our large-scale production capacity, we reduce material waste and machining time, passing savings to you.
- Faster Time-to-Market: With a typical lead time of 5–15 working days for prototypes and 15–25 days for production, you can accelerate your product development cycles.
- Single-Source Supply: We handle everything from raw material procurement to final inspection, packaging, and logistics. You receive fully finished, ready-to-use parts.
- Global Logistics: We ship from major ports (Shanghai, Lianyungang, Qingdao, Tianjin) and have experience with international shipping documentation and customs clearance.
Trust & Reliability: Henan San Kuang Machinery Technology Co., Ltd. has been serving the medical industry since 2022, with a growing export business across North America, South America, Europe, Asia, and Africa. Our factory is certified with multiple management system standards including ISO 9001, ISO 14000, OHSAS 18001, SA8000, and others. We have a dedicated quality team of 10+ inspectors and use state-of-the-art measurement equipment to ensure 100% inspection on critical dimensions. Our customers include leading medical device manufacturers who rely on us for consistent quality and on-time delivery. Contact us today for a quote or to discuss your custom machining requirements. We are ready to support your next medical device project with precision, compliance, and efficiency.
Frequently Asked Questions (FAQ)
-
Q: What is the minimum order quantity (MOQ) for custom medical parts?
A: For prototypes, MOQ is 1 piece. For production, MOQ is typically 100 pieces, but we can accommodate smaller quantities for custom projects. -
Q: Can you machine parts from customer-provided materials?
A: Yes, we accept customer-supplied materials. We will verify their traceability and provide a certificate of conformance. -
Q: Do you offer design assistance for medical devices?
A: Absolutely. Our engineering team provides DFM (Design for Manufacturability) feedback and can help with minor design modifications to improve machinability and reduce costs. -
Q: How do you ensure quality for high-risk medical components?
A: We follow ISO 13485 procedures including process validation, first article inspection, in-process inspection, and final inspection with statistical process control (SPC). Custom inspection plans can be agreed upon. -
Q: What certifications do you hold for medical device manufacturing?
A: We are compliant with ISO 13485, ISO 9001, and several other standards (HACCP, TL900, QS9000, etc.). Our quality management system is audited regularly. -
Q: Can you provide parts with specific surface finish requirements for implants?
A: Yes, we offer electropolishing, passivation, and other finishes to meet ASTM F86 or other implant standards. Surface roughness can be controlled to Ra 0.2 μm or better. -
Q: What is the typical lead time for a custom order?
A: Prototypes: 5–15 working days. Production runs: 15–25 working days, depending on complexity and quantity. Urgent orders can be expedited. -
Q: Do you ship to international destinations?
A: Yes, we export worldwide. We ship from multiple ports and handle all export documentation, including certificates of origin and packing lists.
Send Inquiry to This Supplier
1Yr
Business Type
Manufacturer
Year Established
2022
Factory Size
10,000-30,000 square meters
Annual Export Value
US$2.5 Million - US$5 Million
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