Custom Medical Device Precision Moulds with ±0.01mm Tolerance and ISO 13485 Certification for Surgical Instruments
Price:
30
MOQ:
1
Delivery Time:
15 working days
Brand:
OEM
Product Description
Medical Device Precision Moulding Solutions
Our custom precision moulds and components meet the rigorous demands of the medical device industry, ensuring patient safety and optimal product performance through advanced manufacturing technologies and strict quality control.
Key Industry Requirements
Ultra-Precision Manufacturing
Achieve tolerances as tight as ±0.01 mm for critical components in surgical instruments and diagnostic equipment, ensuring seamless integration and reliable functionality.
Biocompatible Materials
Comprehensive selection of medical-grade materials including silicone, polycarbonate, and ABS, all tested to meet international biocompatibility standards for patient safety.
Sterility & Cleanroom Compliance
Manufactured in controlled cleanroom environments with smooth surface finishes (Ra 0.05 μm) to facilitate effective sterilization and prevent contamination.
Regulatory Certification
Full compliance with FDA, EMA, and ISO 13485 standards, ensuring regulatory approval and safe deployment in healthcare settings.
Advanced Manufacturing Capabilities
We employ state-of-the-art technologies to deliver exceptional precision and quality in medical device components:
- High-speed CNC machining for micron-level accuracy
- Electrical Discharge Machining (EDM) for intricate details
- CMM inspection with micron-level dimensional verification
- Non-destructive testing including X-ray and ultrasonic inspection
Material Selection Expertise
| Material Type | Key Applications | Properties |
|---|---|---|
| Medical-Grade Silicone | Catheters, Seals, Flexible Components | Flexibility, Softness, Biocompatibility |
| Polycarbonate | Device Housings, Lenses, Transparent Parts | Transparency, Mechanical Strength, Durability |
| ABS Plastic | Non-Implantable Components | Impact Resistance, Cost-Effectiveness |
| Titanium Alloys | Implantable Devices | High Strength, Corrosion Resistance, Biocompatibility |
Application Areas
Surgical Instruments
Precision components for forceps, scalpels, and endoscopic devices with firm grip and accurate manipulation capabilities.
Diagnostic Equipment
Critical parts for blood analyzers, X-ray machines, and ultrasound devices requiring accurate sample delivery and analysis.
Implantable Devices
High-precision components for pacemakers, artificial joints, and stents with perfect fit and long service life.
Our custom precision moulding services support medical device manufacturers in developing innovative, life-changing healthcare solutions. Contact us to discuss your specific requirements and benefit from our expertise in medical-grade manufacturing.
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Dongguan Hie Hardware Co., Ltd.
Location
Jinghe Road, Yanyu Village, Dalingshan Town, Dongguan City，Guangdong, China
Contact Person
HIE