GHC standardizes its Healthcare capabilities with international certification IEC 62304:2015 CSV
The IEC 62304:2015 CSV certification marks another important milestone in GHC’s pursuit of the billion-dollar Healthcare vertical. Behind this achievement lies the unwavering commitment of GHC engineers to strengthen core competencies and develop internationally certified medical software.
In late June 2025, shortly after winning the Silver Award in the Digital Health Solutions category at the Globee® Awards, the DentalLAB development team made another breakthrough by obtaining the IEC 62304 certification — a mandatory standard for medical device software. This milestone reinforces the team’s commitment to compliance and reliability for global clients.
The achievement of IEC 62304:2015 CSV reflects GHC’s strategic investment in developing domain-specific capabilities in Healthcare. As a globally recognized standard, IEC 62304 defines rigorous requirements across the entire lifecycle of medical software — from planning, design, and testing to maintenance. Being certified means GHC is now equipped to enter highly regulated markets such as the US, Europe, and Australia.
According to Mr. Do Khanh Hoang, Project Manager of DentalLAB, the certification process fundamentally changed the team’s perspective on medical projects. “Securing IEC 62304 for an AI-integrated SaMD (Software as a Medical Device) product is a significant milestone. It enabled us to build a software development system at the highest standard — but this is only the beginning. We’re now diving deeper, not only in technology but also in areas like healthcare data governance, risk management, and responsible AI”, Hoang said. The next goals include conquering the ISO 42001 certification for AI governance and expanding collaboration with medical experts and organizations to ensure the product delivers real clinical value.
The journey toward IEC 62304:2015 CSV also pushed DentalLAB to develop previously untapped capabilities — from mastering regulatory affairs and establishing a patient safety-first risk management system, to implementing stringent verification, validation (V&V), and quality control processes. “The entire team has grown tremendously throughout this journey. This isn’t just a product success, but a solid foundation for GHC to build specialized healthcare capabilities”, Hoang shared. Following the IEC 62304 milestone, the team will continue to refine advanced features, expand datasets to optimize AI, prepare FDA and CE Mark applications, and progressively enter the global medical market.
Alongside the DentalLAB team, quietly playing a key long-term strategic role is Ms. Doan Thi Bich Hue – PMO of GHC. Having led numerous projects through international standard certifications, Hue doesn’t view IEC 62304 or any certification as a trophy, but rather as essential steps to building core competencies. “My vision is for the team to not only excel in technology but also strictly adhere to specialized standards in Healthcare such as ISO 13485, IEC 62304, and ISO 14971. Additionally, we must understand the regulations governing hospital information systems, pharmaceuticals, and health insurance — from national laws to global standards. That’s what sets us apart from commercial software”, she explained.
According to Ms. Hue, the ability to protect health data is just as critical as meeting technical standards. “This is highly sensitive and vital information, so strict compliance with privacy and security regulations not only safeguards patients but also builds long-term trust with partners and hospitals. In this field, software is not just a data tool — it’s directly tied to human lives. Therefore, accuracy, safety, security, and transparency must always be the top priorities”.
What Ms. Hue truly hopes to see is the day when FPT Software can confidently deliver Healthcare technology solutions that are designed & made by FPT Software, meeting international standards and ensuring absolute patient safety. “Every standard we conquer today opens doors to solutions that help detect diseases earlier, treat them more effectively, ease patient suffering, and shorten recovery time. That is the greatest joy of working in technology”, she shared.
With the motto “Quality is survival”, GHC aims to become a globally recognized VI in healthcare software services. To reach this goal, GHC is rapidly expanding efforts to boost domain knowledge through international Healthcare certifications, ready to stand as a seal of quality for every product delivered by FPT — to clients worldwide.
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