๐ฅ Medical ODM Services
ISO 13485 Certified | Clean Room Manufacturing | FDA Compliant
ISO 13485 Certified Medical Mold 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.
Medical Mold Applications
๐ช Surgical Instrument Molds
Precision molds for surgical tools with strict medical standards and biocompatibility requirements.
- โ Forceps, scissors, clamps, retractors
- โ Endoscopic instrument components
- โ Surgical handles and housings
- โ Disposable surgical tools
๐ฌ Diagnostic Equipment Molds
Injection molds for diagnostic and laboratory equipment with high precision and reliability.
- โ Test chambers and sample holders
- โ Fluid connectors and valves
- โ Sensor housings
- โ Cartridges and cassettes
๐ Drug Delivery Device Molds
Precision molds for pharmaceutical and drug delivery applications with clean room manufacturing.
- โ Inhalers and nebulizers
- โ Injectors and auto-injectors
- โ Pumps and dispensers
- โ Prefilled syringe components
๐ฅ Healthcare Product Molds
Injection molds for medical disposables, patient care products, and hospital equipment.
- โ Medical disposables
- โ Patient monitoring devices
- โ Hospital equipment components
- โ Personal protective equipment (PPE)
Clean Room Manufacturing
๐ญ 100,000 Class Clean Room
Our dedicated clean room facility ensures contamination-free manufacturing with controlled environmental conditions:
- Temperature Control: 20-22ยฐC ยฑ2ยฐC
- 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 | Medical Devices 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:
- ๐ Design History File (DHF)
- ๐ Device Master Record (DMR)
- ๐ Material certifications and traceability
- ๐ Inspection reports and test results
- ๐ Process validation (IQ/OQ/PQ)
- ๐ Clean room monitoring records
Medical Materials Expertise
We work with a wide range of medical-grade plastics:
- โ PP (Polypropylene) – Disposable syringes, containers
- โ PC (Polycarbonate) – Housings, connectors
- โ ABS – Diagnostic equipment, housings
- โ POM (Acetal) – Gears, mechanical parts
- โ PEEK – High-performance implants
- โ TPE/TPU – Soft-touch components
Quality Control
๐ Inspection Capabilities
- 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 Medical Molds?
- ๐ ISO 13485 Certified: Established quality management system
- ๐ญ Clean Room Manufacturing: Contamination-free production
- ๐ Complete Documentation: Full regulatory support
- ๐ฌ Medical Expertise: 10+ years in medical device molds
- ๐ Global Compliance: FDA, CE, ISO standards
- ๐ค Confidentiality: Strict IP protection
๐ง Email: [email protected] | ๐ฑ WhatsApp: +8613037600603
๐ Address: Rm. 2-2502, No. 63 Qinling Road, Zhengzhou, Henan, China
