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ISO 13485:2016 Certified Cleanroom Medical Plastic Injection Molding with Full IQ/OQ/PQ Validation
ISO 13485:2016 Certified Cleanroom Medical Plastic Injection Molding with Full IQ/OQ/PQ Validation
Specifications
Brand Name :
Creator
Model Number :
KD-MED-001
Place of Origin :
Xiamen, Fujian, China
Certification :
ISO 13485:2016
MOQ :
100 Pieces
Price :
Negotiation
Payment Terms :
T/T, L/C, PayPal, Western Union
Supply Ability :
100000 Pieces per Month
Delivery Time :
25-35 working days for new mold, 7-15 days for production
Packaging Details :
Export-grade carton with PE bag, palletized for container shipment
Cleanroom Class :
ISO Class 8 (100,000)
Validation :
IQ/OQ/PQ Protocol
Description

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

CertificationISO 13485:2016, ISO 9001:2015
Cleanroom ClassISO Class 8 (100,000)
Mold MaterialS136, NAK80, 420 Stainless Steel
Plastic MaterialMedical-grade PC, ABS, PP, PEEK, PSU, PEI
Mold Precision±0.01mm
Injection Machine80 - 500 ton (dedicated medical line)
ValidationIQ/OQ/PQ Protocol
SterilizationEtO, 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.

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ISO 13485:2016 Certified Cleanroom Medical Plastic Injection Molding with Full IQ/OQ/PQ Validation

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Product Detail
Brand Name :
Creator
Model Number :
KD-MED-001
Place of Origin :
Xiamen, Fujian, China
Certification :
ISO 13485:2016
MOQ :
100 Pieces
Price :
Negotiation
Contact Supplier
ISO 13485:2016 Certified Cleanroom Medical Plastic Injection Molding with Full IQ/OQ/PQ Validation

Xiamen Creator Technology

Verified Supplier
7 Years
fujian, xiamen
Since 2007
Business Type :
Manufacturer, Exporter, Trading Company, Seller
Main Products :
Injection Molding Services, Plastic Injection Molding Service, Dual Shot Injection Molding
Total Annual :
2000000-3000000
Employee Number :
40~50
Certification Level :
Verified Supplier
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