Quality control system (Medical device outsourcing business)

We have established a quality control system based on the QMS Ministerial Ordinance (Quality Management System), which complies with GVP Ministerial Ordinance (Safety Management Standards) as well. We have acquired license for manufacturing and selling business of medical device and registered as a medical device manufacturer by Japanese reulations.

In addition to clearance of ISO 13485 and US based QSR, we understand MDR based European QSR standard that has been recently updated. With the utilization of those expertise, we fully support your medical device business internationally.

Quality control system (Manufacturing business)

We have acquired ISO13485 certification, which is the QMS (quality management system) for medical devices, and we have QMS for our manufacturing services business following ISO9001.

Each processing data is centrally managed and stored to maintain the high quality of not only the products to be delivered, but also for subsequent repeated orders.

ISO certification information

ISO13485 certification

ISO14001 certification