ISO 13485:2016 Certified Cleanroom Medical Plastic Injection Molding with Full IQ/OQ/PQ Validation
ISO 13485 Cleanroom Medical Plastic Injection Molding Service with Full Validation Protocol
Certified to ISO 13485:2016, Xiamen Creator Technology Co., Ltd. provides cleanroom injection molding services for medical device components. Our ISO 13485 quality management system covers the complete product lifecycle from design validation through production, packaging, and sterilization compatibility verification.
Key Features & Advantages
- ISO 13485:2016 certified quality management system for medical devices
- Class 100,000 (ISO 8) cleanroom injection molding environment
- Full IQ/OQ/PQ validation protocol documentation
- Biocompatibility testing support per ISO 10993 standards
- Sterilization-compatible material selection (EtO, Gamma, Autoclave)
- Complete device history records (DHR) for every production lot
Technical Specifications
| Certification | ISO 13485:2016, ISO 9001:2015 |
| Cleanroom Class | ISO Class 8 (100,000) |
| Mold Material | S136, NAK80, 420 Stainless Steel |
| Plastic Material | Medical-grade PC, ABS, PP, PEEK, PSU, PEI |
| Mold Precision | ±0.01mm |
| Injection Machine | 80 - 500 ton (dedicated medical line) |
| Validation | IQ/OQ/PQ Protocol |
| Sterilization | EtO, Gamma, Autoclave compatible |
Manufacturing Excellence
Our dedicated medical injection molding workshop features an ISO Class 8 cleanroom with positive pressure, HEPA filtration, and temperature/humidity control. All production personnel follow strict gowning procedures. Our ISO 13485-certified quality system ensures complete traceability from raw material receipt through finished product release, with full validation documentation and device history records maintained for every production lot.
Frequently Asked Questions
Q: Do you have ISO 13485 certification?
A: Yes, we are certified to ISO 13485:2016 for the design and manufacture of medical device components. Our certificate is current and available for review.
Q: What cleanroom class do you operate?
A: We operate an ISO Class 8 (Class 100,000) cleanroom with HEPA filtration, positive pressure, and controlled temperature and humidity.
Q: Can you support sterilization validation?
A: Yes. We work with materials compatible with EtO, Gamma, and Autoclave sterilization. We can coordinate with your sterilization provider for validation testing.
Q: Do you provide full device history records?
A: Absolutely. We maintain complete DHR for every production lot including material certs, process parameters, inspection records, and final release documentation.
Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.