Cellumed, ISO 13485 Re-Certification Obtained... Proving Global-Level Medical Device Production System

Bio medical device manufacturing specialist Cellumed announced on the 9th that it has passed the ISO 13485 recertification audit and renewed its certification for the international standard of medical device quality management systems.

ISO 13485 is a global certification for medical device quality management systems established by the International Organization for Standardization (ISO). Companies that obtain this certification demonstrate that they meet strict international regulations throughout the entire process from product development to production and distribution.

Through this recertification, Cellumed once again proved its production capabilities in its core products, 'bone formation therapeutics' and 'artificial knee joints.' In particular, the company focused on advancing quality management, receiving evaluations that it has significantly strengthened product competitiveness and market responsiveness.

Since the end of last year, the company has formed a company-wide 'Production Process TFT' to enhance quality improvement activities throughout the medical device development and manufacturing processes. By organizing a system for early identification and prevention of quality risks and dedicating efforts to improving consistency and efficiency in production processes, Cellumed succeeded in more than doubling the production capacity of its bone formation therapeutic DBM (Demineralized Bone Matrix) earlier this year compared to before.

Having completed preliminary inspections such as validation, Cellumed expects meaningful sales expansion to be possible as early as the second quarter of this year.

Cellumed’s flagship bone formation therapeutic, 'Rapugen DBM,' is a gel-type bone graft material certified by the U.S. FDA. It rapidly induces bone regeneration at bone defect sites and is characterized by a high DBM content that promotes fast bone formation.

Additionally, the artificial knee joint product is the first domestically produced product in Korea made entirely of titanium alloy for both the femoral and tibial components. According to the company, it is more than twice as light as existing cobalt-chromium alloy products and offers superior patient convenience due to reduced foreign body sensation after surgery.

A Cellumed representative stated, "Implantable products require the strictest quality control standards above all else. With the ISO 13485 recertification, our production reliability has been internationally recognized, and we will accelerate efforts to expand production volume and sales."

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