Phantomics is proud to announce that we've received ISO13485 certification. ISO13485 is an internationally standardized medical device quality management system that stipulates the consistent maintenance of the safety and quality of medical device software throughout its lifecycle - from design and development to production, service, and end-of-life. 

The ISO13485, a requirement for the manufacturing and sales of medical devices certification, paves the way for Phantomics to expand its global reach for Myomics and other products.

Phantomics' main products, Angiomics and Myomics, are Software as Medical Device (SaMD), and all employees participated in the development, modification and approval processes based on international standards.

Phantomics is currently conducting collaborative research with a number of general hospitals and academic institutions. Also, Phantomics is working to acquire the domestic approval of Angiomics and the European and US approval of Myomics later this year.

Phantomics will continue to improve its quality management system to maintain compliance with the latest medical device regulations, and strive to efficiently develop internal processes to ensure that safe products reach the market.