Quality Management


Certified by ISO13485 and QMS

Strong Biotech is dedicated to improving the quality of healthcare products. Since 2008, it has been a pioneer in obtaining the international certification of the European Union’s ISO13485 medical device quality system. In 2012, it acquired the license for domestic medical device products, and in 2013, it established its own manufacturing facility, passing the Department of Health’s QMS medical device quality management system standards, the European Union’s CE certification, and product registration certifications in multiple countries, ensuring product quality, efficiency, and safety. With over 20 years of accumulated experience in research, design, and manufacturing, Strong Biotech provides high-quality medical products, contributing to global health.

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Quality Management


Pharmacist Manufacturing License


Medical Device License


QMS Certificate


QMS Certificate


CE Registration Certificate


BSI-ISO13485 Certificate