ISO13485 Medical Devices Quality Management System Certificate


12 Apr. 2019

ISO13485 is an international standard concerning the quality management system specializing in the medical device industry. Shinano Kenshi Co., Ltd. has acquired the ISO13485 certificate for compliance of medical device directives and regulations, and also continuously ensures the safety and quality of medical devices. The certificate covers the following activities:

  1. Design and manufacture of compressors for active medical devices
  2. Manufacture of blowers for active medical devices