- Outsourcing of R&D
- Global production
- Stable supply chain
It is possible to achieve manufacturing in consideration of both quality and cost mainly of single-use medical devices, including absorbable/non-absorbable medical devices made from biocompatible materials, biosensors, surgical instruments and medical cables. The manufacturing system is integrated from prototype to mass production, making it possible to realize smooth scheduling.
Besides the Kyoto Factory, there are manufacturing sites located in the U.S., the U.K., France, the Dominican Republic, Malaysia and China in view of future business expansion overseas.
End to end manufacturing at Kyoto
We will discuss development and manufacturing, not only in Japan, but also towards global expansion with you at the Kyoto Factory to ensure unified management of development, manufacturing and regulatory approval for your reassurance.
The craftsmanship of MADE IN KYOTO and the global network of NISSHA Medical Technologies contribute to the evolution and growth of medical devices.
Class 10,000 clean rooms
Control system of clean rooms in accordance with the QMS Ministerial ordinance (Quality Management System) standard for the manufacture/quality control of craftsmanship for medical devices.
The system uses ISO13485 and the QMS Ministerial Ordinance as the standard, corresponding to Class 10,000 cleanliness.
Experts in craftsmanship in clean rooms support the manufacturing processes.
Global network
A consistent system from engineering to manufacturing is possible based on the Innovation Center and Kyoto Factory on the premises of the Kyoto Headquarters.
There are 11 manufacturing sites of medical devices of our company, including Kyoto Headquarters, in the world; all of the sites have ISO13485:2016 certification. Especially for the U.S. market, the factory in the Dominican Republic takes the role of mass production. Its manufacturing space covers a total area of 23,000 m2 and over 400 workers are employed. It is highly competitive in the international market both as far as quality and costs are concerned.
Our capabilities
We have supplied high value-added products with high processing technology in various industries including IT and mobility. “Six core technologies” support the NISSHA craftsmanship.
Based on these technologies, the available wealth of knowledge on various materials is jointly used to solve customer problems. We achieve products with high performance and high quality.
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Printing
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Coating
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Laminating
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Molding
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Patterning
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Metal processing
Cost reduction
Plan in line with the product life style of medical devices from a small amount to mass production
The manufacturing system is proposed by the Project Manager
- Transfer of the manufacturing line
- Establishment and operation of the manufacturing process
- Assembly/manufacturing/sterilization of final product/parts
Medical device
manufacturing site
