Cellreturn Obtains ISO13485 Medical Device Quality Certification

[Asia Economy Reporter Yujin Cho] Beauty healthcare specialist Cellreturn announced on the 22nd that it has obtained the ISO 13485:2016 (hereinafter ISO 13485) certification, an international standard medical device quality management system.

ISO 13485 is an international standard certification system established by the International Organization for Standardization (ISO) that verifies whether a quality management system for medical devices is in place.

A Cellreturn official stated, "This certification is a mandatory standard for companies providing medical device-related services on the global stage. Companies that receive this certification are evaluated as having the appropriate requirements to export medical devices to major countries worldwide."

After obtaining the medical device GMP compliance certification from the Ministry of Food and Drug Safety around June, Cellreturn has now acquired the international standard certification, enhancing its external credibility and competitiveness in medical device quality management capabilities. As a result, it is expected to facilitate entry into the global beauty medical device market, which is projected to grow at an average annual rate of over 7%.

Currently, Cellreturn is developing beauty and medical devices based on the principle of low-level light therapy (LLLT), leveraging domestic and international patents related to LED modules that promote the output of effective wavelengths and its medical device quality management capabilities. Starting in the second half of the year, the company plans to expand its business areas from beauty to healthcare by building a broad portfolio.

A Cellreturn official said, "Due to the impact of the novel coronavirus infection (COVID-19), industrial and safety standards are rising in overseas countries, and the competitiveness of medical device quality management certification is being evaluated more highly. From the second half of this year, full-scale business diversification is expected, creating synergy between beauty and healthcare businesses, making this year a milestone for the company’s leap forward."

This content was produced with the assistance of AI translation services.