VINBRAIN RECEIVES ISO 13485:2016 CERTIFICATION FOR QUALITY, AFFIRMING ITS GLOBAL COMPETITIVENESS IN THE FIELD OF HEALTHTECH

Feb 24 (Hanoi) - VinBrain's DrAid™ - one of the four flagship products - was honored to receive the ISO 13485:2016 certification from ISOCERT, an international certification and inspection company, affirming DrAid™'s ability to meet international quality standards. 

The ISO 13485:2016 certification is an internationally recognized standard for quality management systems in the medical device industry, which stipulates requirements for comprehensive quality management systems that ensure the safety and effectiveness of medical devices in their design, development, and delivery. 

 
DrAid™ receives ISO 13485:2016
 

Currently, DrAid™ is VinBrain's platform that supports the screening of 31 abnormal signs with high accuracy and speed, serving as a AI assistant for doctors and healthcare professionals worldwide. Specifically, DrAid™ is AI-as-a-service platform in diagnosis, patient medical record management, and patient interaction. 

With ISO 13485 certification in hand, VinBrain has solidified its position as a leading provider of advanced healthcare solutions that meet the highest quality standards. This is the basis for DrAid™ to obtain healthcare professionals' trust. VinBrain hopes that achieving the ISO 13485 standard will create an impact in demanding high standards for healthcare leaders in pursuing the 3 important points of standardization, simplification, and automation when applying hightech in healthcare, in order to improve the effectiveness of healthcare quality at medical facilities. 

Prior to ISO, VinBrain received approval from the US Food and Drug Administration (FDA) for DrAid™ for Radiology V1, an AI-enabled triage and notification software designed to aid the clinical assessment of adult Chest X-ray cases with features suggestive of pneumothorax 

"We are proud to have received the ISO 13485:2016 certification for DrAid™," said Steven Truong, CEO of VinBrain. "This certification is an important milestone in our development process and product enhancement, and it is our commitment to bringing a product not only for Vietnamese people but also for the world."