COMPANY
MANUFACTURING
Nu Eyne performs process validation and manufacturing management in compliance with international standards and the regulatory requirements of advanced healthcare markets worldwide.
Nu Eyne performs process validation and manufacturing management in compliance with international standards and the regulatory requirements of advanced healthcare markets worldwide.
Manufacturing Management
Manufacturing management is critical to ensuring the quality of medical devices. To consistently maintain the safety and effectiveness of medical devices, manufacturing processes must comply with international standards and country-specific regulatory requirements.
Manufacturing Facilities
Nu Eyne's manufacturing facility is equipped with world-class quality systems and production capabilities.
The facility has been designed to comply with the requirements of:
Nu Eyne has obtained all relevant quality system certifications.
Manufacturing Facilities
Manufacturing Facilities
Nu Eyne's manufacturing facility is equipped with world-class quality systems and production capabilities.
The facility has been designed to comply with the requirements of:
Nu Eyne has obtained all relevant quality system certifications.
Product Testing
To ensure the safety, reliability, and performance of its products, Nu Eyne conducts a wide range of testing procedures tailored to each product.
Safety Testing
Biological Safety Testing
- Cytotoxicity Test (ISO-10993-5)
- Skin Irritation Test (ISO-10993-10)
- Sensitization Test (ISO-10993-10)
Electrical and Mechanical Safety Testing
General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment (IEC 60601-1)
Electromagnetic Compatibility (EMC) Testing
Electromagnetic Safety Testing
(IEC Standards)
Usability Testing
Usability Engineering for Medical Devices (IEC 60601-1-6)
Home Healthcare Environment Testing
Medical Electrical Equipment and Systems Used in Home Healthcare Environments (IEC 60601-1-11)
Low-Frequency Stimulator Testing
Particular Requirements for Basic Safety and Essential Performance of Nerve and Muscle Stimulators (IEC 60601-2-10)
Photobiological Safety Testing
Photobiological Safety of Lamps and Lamp Systems (IEC 62471)
Performance Testing
Product-specific performance testing tailored to each device
Shelf-Life Testing
Accelerated Aging and Shelf-Life Validation Testing (ASTM F1980-16) (Ongoing)
Additional Reliability Testing
Reliability Testing (IEC 60068)
- Vibration Testing
- Drop Testing
- High Temperature & Humidity Testing (Storage and Operation)
- Low Temperature Testing (Storage and Operation)
- Aging Testing
Product Testing
To ensure the safety, reliability, and performance of its products, Nu Eyne conducts a wide range of testing procedures tailored to each product.
| Safety Testing | Biological Safety Testing - Cytotoxicity Test (ISO-10993-5) - Skin Irritation Test (ISO-10993-10) - Sensitization Test (ISO-10993-10) |
| Electrical and Mechanical Safety Testing | General Requirements for Basic Safety and Essential Performance of Medical Electrical Equipment (IEC 60601-1) |
| Electromagnetic Compatibility (EMC) Testing | Electromagnetic Safety Testing (IEC Standards) |
| Usability Testing | Usability Engineering for Medical Devices (IEC 60601-1-6) |
| Home Healthcare Environment Testing | Medical Electrical Equipment and Systems Used in Home Healthcare Environments (IEC 60601-1-11) |
| Low-Frequency Stimulator Testing | Particular Requirements for Basic Safety and Essential Performance of Nerve and Muscle Stimulators (IEC 60601-2-10) |
| Photobiological Safety Testing | Photobiological Safety of Lamps and Lamp Systems (IEC 62471) |
| Performance Testing | Product-specific performance testing tailored to each device |
| Shelf-Life Testing | Accelerated Aging and Shelf-Life Validation Testing (ASTM F1980-16) (Ongoing) |
| Additional Reliability Testing | Reliability Testing (IEC 60068) - Vibration Testing - Drop Testing - High Temperature & Humidity Testing (Storage and Operation) - Low Temperature Testing (Storage and Operation) - Aging Testing |
Certifications and Global Regulatory Approvals
Nu Eyne has obtained internationally recognized quality system certifications, including:
- Domestic GMP Certification (Korea)
- International Quality System Certifications
In addition, Nu Eyne has secured product approvals in multiple countries, demonstrating the safety, quality, and competitiveness of its medical technologies.
