Biostandard, an anti-aging total care company, announced on the 25th that it has acquired ISO 13485 certification, an international standard medical device quality management system.

The accredited agency in charge of this certification is TUV SUD, a global technology solutions company with over 150years of history and headquartered in Munich, Germany, and has a reputation as the most demanding certification agency in the medical device field.


ISO (International Organization for Standardization) 13485 is a quality management system standard specific to the medical device industry and is a certification system that includes requirements for quality management and management systems that meet international requirements from design and development to production of medical devices.

The quality of medical devices directly affects not only user safety but also their effectiveness, so strict quality control is required. ISO 13485 is an international standard adopted by major countries around the world, so medical device companies targeting the global market are required to This is a certification that must be obtained. As a result, Biostandard is evaluated as having been objectively recognized for its system and operational capabilities for producing and managing medical devices.

A Biostandard official said, “With this ISO 13485 certification, we plan to secure quality competitiveness within the industry and continuously provide high-quality products and services by renewing ISO 13485 every year.” He added, “We plan to increase our brand value in the global market by expanding overseas exports.” “We expect to increase our reputation and grow into a more trustworthy company.”