With a strong track record working with top-tier global medical device manufacturers, we are chosen by customers as a trusted development and manufacturing partner.
Key Reasons Global Customers Choose Nissha
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- Mass Production with Multi‑Material Expertise
- Building on technologies rooted in printing, Nissha has accumulated extensive experience in processing a wide range of materials, including liquids, films, resins, and metals.
By understanding the unique characteristics and constraints of each material, we design manufacturing processes with scalability in mind, supporting a smooth transition to stable mass production and reducing rework and the risk of design changes.
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- Proven Experience in Mass Production of Specially-Controlled Medical Devices
- Based on our experience in mass production of specially-controlled medical devices, we support stable production even for products with stringent quality requirements.
Nissha's process design anticipates challenges likely to arise during the mass production phase, enabling customers to outsource manufacturing with confidence.
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- Cleanroom Operations Optimized for Medical Device Manufacturing
- We have established cleanroom environments suitable for medical device manufacturing and have extensive experience in mass production under controlled clean conditions.
Cleanroom control is integrated into process design, enabling stable manufacturing for products with stringent quality requirements.
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- Quality Management Systems Supporting Mass Production
- We operate under a quality management system compliant with ISO 13485 and the Japanese QMS Ordinance, with established traceability and record control.
The system supports impact assessment, change management, and corrective actions during mass production.
In mass production transfer, we design processes that address quality variation and process risk.
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- Globally Coordinated Manufacturing Management
- Our globally coordinated management system enables manufacturing sites in Japan and overseas to share regulatory expertise across locations.
Depending on product characteristics, we leverage overseas sites to propose manufacturing structures that consider quality, cost, and sourcing.
