FPT Software has successfully re-appraised its ISO 13485:2016 certification for two consecutive years, following a rigorous assessment of its medical device software development projects across Hanoi, Can Tho, and Ho Chi Minh City. The assessment was conducted by SGS, the world’s leading inspection and certification. SGS has recognized the company’s efforts in improving processes and fully complying with the requirements of the ISO 13485 standard.
FPT Software initially achieved ISO 13485:2016 in 2022. The certification will be valid for three years with annual scrutiny and monitoring. The recent assessment encompassed thorough evaluation meetings with numerous projects from the FPT Software’s departments.
Healthcare is among FPT Software's focused domains, in which it aims to transform the industry's platforms and services through intelligent, cloud-based solutions that increase resource capacity, enhance workforce productivity, enable connect data for personalized services across channels, and improve the quality of care for patients and caregivers.
The accomplishment reaffirms FPT Software's steadfast dedication to maintaining the utmost quality standards in its development of medical device software, reinforcing the trust and confidence of its existing partners. This also highlights the company’s established proficiency as a world-class technology solutions provider for complex business challenges and opportunities.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide Medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device, and design and development or provision of associated activities (e.g., technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.