ISO 13485(Medical Device Quality Management System)
The ISO 13485 standard is a standard that stipulates the requirements for an organization's system that designs, develops, produces, installs, and provides additional services for medical devices created by adding special requirements to medical devices based on ISO 9001 standards.
The establishment of a quality management system unique to medical device companies that can ensure the safety of medical devices is recognized as a basic factor in foreign and export companies, and obtaining ISO13485 certification is essential.


  • Additional points applied when evaluating companies
  • Raising awareness of quality management and making it a habit
  • Establish a rational and efficient management system
  • Productivity improvement through systematic work execution
  • Secure quality competitiveness by establishing work system
  • Active and efficient means of preparing for domestic and foreign environmental changes
  • Responding to customer authentication requirements
  • Expansion into international and domestic markets


  • Raising goal awareness through performance analysis against policies and goals
  • Enhancement of corporate competitiveness by improving management constitution
  • Improved reliability through objective verification of management system
  • Customer satisfaction through prevention, removal of wasteful elements, and improvement
  • Increase sales and profits through technology accumulation and cost reduction
  • ISO 13485(9001) system is the cornerstone of corporate innovation
  • Improved ability to actively cope with changes in production and business environment