03-07-2025
Mahidol Lab First in ASEAN with ISO 13485
Mahidol University's Faculty of Engineering has become the first in Thailand and ASEAN to receive ISO 13485:2016 certification for its innovation in antibacterial nano-coatings on dental implants—a milestone that brings the research closer to clinical application and commercialisation.
The certification was awarded to the Laboratory of Drug Delivery System for Medical Devices for its nano-coating technology designed to reduce bacterial infections on dental implants. This breakthrough responds to a critical need in dentistry, where up to 80% of implant patients experience mild inflammation and 20% face severe bone loss due to infection.
Led by Assoc. Prof. Dr. Noraset Nasongkla and Dr. Chalaisorn Thanapongpibul, in collaboration with the Faculty of Dentistry's Assoc. Prof. Dr. Saranya Tanchareon, the project showcases Mahidol's strength in interdisciplinary research. Assoc. Prof. Dr. Thanapat Wanichanon, Dean of the Faculty of Engineering, credited the achievement to strong collaboration and Mahidol's dedication to research that meets global standards.
Assoc. Prof. Dr. Bundit Jirajariyavej, Dean of the Faculty of Dentistry, confirmed that the nano-coated implants will soon undergo clinical trials—an essential step toward real-world use that could improve patient outcomes and reduce reliance on imported technologies.
ISO 13485:2016 is a globally recognised standard for quality management systems in medical devices, ensuring that certified organisations consistently meet regulatory and safety benchmarks. 'This certification is more than a symbol—it's a foundation of trust,' said Robert Frolich, Vice President of Medical Health Services (ASEAN) at TÜV SÜD PSB Singapore.
This achievement not only elevates Thailand's profile in high-value medical innovation but also underscores Mahidol University's role as a 'University of Innovation,' transforming academic research into impactful, scalable healthcare solutions.
