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🏥 Медицина ODM Услуги
ISO 13485 Certified | Clean Room Производство | FDA Compliant
ISO 13485 Certified Медицина Пресс-форма Manufacturer
Tuohai Tech specializes in high-precision injection molds for medical devices, including surgical instruments, diagnostic equipment, drug delivery devices, and healthcare products.
Our ISO 13485 certified facility ensures the highest quality standards for medical device manufacturing.
Медицина Пресс-форма Применение
🔪 Surgical Instrument Пресс-формаs
Прецизионный molds for surgical tools with strict medical standards and biocompatibility requirements.
- ✅ Forceps, scissors, clamps, retractors
- ✅ Endoscopic instrument components
- ✅ Surgical handles and housings
- ✅ Disposable surgical tools
🔬 Diagnostic Equipment Пресс-формаs
Injection molds for diagnostic and laboratory equipment with high precision and reliability.
- ✅ Test chambers and sample holders
- ✅ Fluid connectors and valves
- ✅ Sensor housings
- ✅ Cartridges and cassettes
💉 Drug Delivery Device Пресс-формаs
Прецизионный molds for pharmaceutical and drug delivery applications with clean room manufacturing.
- ✅ Inhalers and nebulizers
- ✅ Injectors and auto-injectors
- ✅ Pumps and dispensers
- ✅ Prefilled syringe components
🏥 Здравоохранение Product Пресс-формаs
Injection molds for medical disposables, patient care products, and hospital equipment.
- ✅ Медицина disposables
- ✅ Patient monitoring devices
- ✅ Hospital equipment components
- ✅ Personal protective equipment (PPE)
Clean Room Производство
🏭 100,000 Class Clean Room
Our dedicated clean room facility ensures contamination-free manufacturing with controlled environmental conditions:
- Temperature Control: 20-22°C ±2°C
- Humidity Control: 45-55% RH
- HEPA Filtration: ISO Class 8 (Class 100,000)
- Positive Pressure: Prevents contamination
- Gowning Procedures: Strict personnel protocols
Regulatory Compliance
| Certification | Scope |
|---|---|
| ISO 13485:2016 | Медицина Устройства QMS |
| FDA Compliant | 21 CFR Part 820 |
| CE Marking Support | EU MDR compliance |
| Biocompatibility | ISO 10993 testing |
Documentation & Traceability
Complete documentation package for medical device regulatory submissions:
- 📄 Проектирование History File (DHF)
- 📄 Device Master Record (DMR)
- 📄 Материал certifications and traceability
- 📄 Inspection reports and test results
- 📄 Process validation (IQ/OQ/PQ)
- 📄 Clean room monitoring records
Медицина Материалs Expertise
We work with a wide range of medical-grade plastics:
- ✅ PP (Polypropylene) – Disposable syringes, containers
- ✅ PC (Polycarbonate) – Housings, connectors
- ✅ ABS – Diagnostic equipment, housings
- ✅ POM (Acetal) – Gears, mechanical parts
- ✅ PEEK – High-performance implants
- ✅ TPE/TPU – Soft-touch components
Качество Control
🔍 Inspection Возможности
- CMM Inspection: Zeiss and Mitutoyo coordinate measuring machines
- First Article Inspection (FAI): Complete dimensional verification
- Visual Inspection: Trained inspectors, controlled lighting
- Functional Testing: Assembly and performance testing
Why Choose Tuohai Tech for Медицина Пресс-формаs?
- 🏆 ISO 13485 Certified: Established quality management system
- 🏭 Clean Room Производство: Contamination-free production
- 📋 Complete Documentation: Full regulatory support
- 🔬 Медицина Expertise: 10+ years in medical device molds
- 🌍 Global Compliance: FDA, CE, ISO standards
- 🤝 Confidentiality: Strict IP protection
📧 Email: [email protected] | 📱 WhatsApp: +8613037600603
📍 Address: Rm. 2-2502, No. 63 Qinling Road, Zhengzhou, Henan, China
