Jan
19
On June 12, the 3D Technology in Medicine Center (3D Lab) at VinUniversity was officially certified as meeting international standards for quality management systems (ISO 9001:2015) and medical device quality management systems (ISO 13485:2016) by the International Certification and Inspection Organization ISOCERT.
Specifically, the certified scope covers the production of personalized orthopedic implants, including upper and lower limb bones, spine, skull, and maxillofacial structures; dental implants; cranial patches; esophageal and cardiovascular stents; customized plates and fixation devices; 3D anatomical models; and patient-specific surgical navigation devices.
To date, only a limited number of organizations in Vietnam have achieved ISO certification in the field of 3D medical device manufacturing, underscoring the pioneering role and significance of 3D Lab. This ISO certification represents a major milestone, laying an important foundation for the future development of 3D technology–based medical device manufacturing in Vietnam.
With this recognition, 3D Lab not only strengthens confidence in the quality and reliability of its 3D-manufactured products but also establishes a solid basis for the application of 3D technology in medical education and research. The center’s 3D anatomical models will support the teaching of rare and complex clinical cases that conventional models cannot adequately represent. In addition, fully personalized implant products—designed entirely based on individual patient data—are tailored to each patient’s anatomy, contributing to improved treatment outcomes.
Ms. Nguyen Thi Hong Nhung, Deputy Director of ISOCERT, shared:
“To obtain this certification, the 3D Technology Center underwent an independent and objective certification assessment process and demonstrated full compliance with ISO requirements. The center has invested in staff training to ensure a thorough understanding of quality management systems, standardized professional experience into applicable procedures, and implemented a well-structured internal audit process. We believe the Center will continue to grow and become a leading technical partner for clients in its field.”
At the event, Associate Professor Le Cu Linh, Executive Vice Director of the Institute of Health Sciences at VinUniversity, reaffirmed the strategic vision of 3D Lab:
“Our goal is to become a leading startup hub in the application of 3D technology in healthcare, while also fostering deep and extensive collaboration with experts both domestically and internationally.”
This achievement reflects the broader development strategy of the Institute of Health Sciences in particular, and VinUniversity as a whole, to become a pioneering force in creating positive impacts on Vietnam’s healthcare system, elevating its position regionally and internationally, and contributing to the service of humanity.
