Manufacturing medical devices
-from design to mass production-

Provides one-stop, stable craftsmanship from design to manufacturing utilizing the manufacturing system and high technical capabilities based on ISO13485
Solves customer issues through contract manufacturing organization (CMO) and contract development and manufacturing organization (CDMO) of medical devices with Kyoto Factory as the starting point

We will use the manufacturing system based on ISO13485 and our knowledge of processing techniques/materials to solve the issues posed by customers in the development/manufacture of endoscopic instruments used for minimally invasive treatments, biocompatible (absorbable, non-absorbable) medical devices, and biosensors.


NISSHA Group's technologies are consolidated into the field of medical devices to provide
design/development/manufacturing services in an integrated manufacturing system.

Contract manufacturing organization

  • Outsourcing of manufcturing for resource-intensive R&D
  • Creating a competitive mass-production system globally
  • Realizing stable supply chain

Possesses Class 10,000 clean rooms in Kyoto. The Innovation Center on our premises allows a consistent system spanning from engineering to manufacturing.
We also have multiple manufacturing sites that can handle our anticipated global expansion of medical device manufacturing.

Contract development and manufacturing organization

  • Proposal of optimal processing methods
  • Proposal of optimal materials and combinations
  • Proposal of Establishment of a global manufacturing

We design costs and scheduling based on the points to smoothly proceed through regulatory approval/accreditation.


  • Providing cutting-edge technology
  • Handling various material components - plastics, rubbers, metals and biomatrials
  • Contributing to improve QOL (quality of life)

We will introduce the details of functional medical devices that only NISSHA can produce through our commitment to design and comfort of use.

Inquiries about design development/
manufacturing of medical devices

Please feel free to contact us about medical devices

Contact US