Advanced BioMedical Technologies has obtained ISO 13485:2003 certification for its quality management system (QMS).
The company’s commercial products include orthopaedic internal fixation devices comprising of proprietary high grade polymers, which allows the body to degrade the products during the healing process.
The QMS, which has been certified by the Chinese SFDA to meet YY/T 0287-2003 standard – the Chinese equivalent of ISO 13485:2003, allows manufacturers to apply for production permits and product registrations.
Advanced BioMedical Technologies CEO Wang Hui said the SFDA certified QMS will enable the company to manufacture and market its products once they are approved by the SFDA.
"Furthermore, Quality Management Systems around the world are generally based on ISO 13485; this certification will help the Company to be accredited in other countries in due course," Hui added.