- Comprehensive Test Line for Clinical and Non-Clinical Sample Production
- Quality Management Based on QMS Regulations
- Full Support from Sample Production to Mass Production
At Nissha, we offer not only mass production of medical devices but also contract manufacturing services for clinical and non-clinical samples. We provide seamless engineering and manufacturing support from sample production through to mass production, ensuring rapid product commercialization.
High-Quality Services in a Clean Test Line
Dedicated Test Line for Sample Manufacturing
Our Innovation Center at the Global Headquarters in Kyoto features a dedicated test line room designed specifically for sample manufacturing. We can handle small-scale and spot production of clinical and non-clinical samples. Additionally, we can install clean booths to maintain cleanliness levels tailored to each product's requirements. The mass production factory is located within the same Global Headquarters premises in Kyoto, allowing for smooth transitions to mass production.
Area: Approximately 320 square meters Ceiling Height: Approximately 8.3 meters
Reliable Quality Management System Based on QMS Regulations
At Nissha, we can establish our quality management system that adheres to QMS (Quality Management System) regulations not only in our mass production factories but also in our test line rooms. By establishing a QMS framework during the setup of clinical and non-clinical sample manufacturing lines, we provide secure and reliable service for our clients.
Consultation for Medical Device Development
and Manufacturing Contracts
Nissha offers comprehensive contract services from clinical and non-clinical sample manufacturing to mass production for medical devices. Please feel free to contact us for any inquiries regarding the development and manufacturing of medical devices.
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