CMO - Manufacturing medical devices -from design to mass production

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.

Comprehensive End-to-End manufacturing solutions for your devices centered in Kyoto

We excel in managing contract manufacturing solutions for your devices, both domestically and internationally. Leveraging our extensive global footprint, we ensure seamless operations and high-quality production no matter where you are.
The craftsmanship of MADE IN KYOTO and the global network of NISSHA Medical Technologies contribute to the evolution and growth of medical devices.

Transfer of the manufacturing line
Establishment and operation of the manufacturing process
Manufacturing / Assembly of finish devicses / components /packaging / sterilization

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 cleanroom manufacturing support the entire production process from manufacturing, assembly, inspection, packaging, sterilization , to delivery.
We also offer contract packaging services, including sterilization, derivery, storage, and delivery to end-users.

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 14 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.

We provide End to end contract solutions
from manufacturing to delivery

We handle the procurement of radiation-resistant packaging materials for sterilization and containers/bags as specified by our customers.We offer comprehensive sterilization services for your products.Assembly and packaging can be customized into kits or combined packaging solutions. We streamline the manufacturing process of medical devices with high quality.

Solutions from manufacturing to delivery.
We provide comprehensive contract services.

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.