Biounit acquires 'ISO 13485' International Standard Certification for Medical Devices

Amid the recent growing demand for endoscopic electrode medical devices domestically and globally, the company received international standard medical device certification in April 2023, opening the door for surgery not only in Korea but also abroad. 

Biounit recently obtained international standard certification for 'ISO 13485', a medical device quality management system, from the global testing and certification agency (KIWA). 

ISO 13485 certification is a certification system that determines whether it has a management system and quality management system that meet international requirements from medical device development to production. Through this certification, we will take the lead in globalizing domestic medical devices and development systems by obtaining the stability of medical devices and certification of products from FDA and CE.