- AI-driven Organ Regeneration Platform Completes TÜV SÜD Cybersecurity Verification
- Integrated Security Proven Across App, Cloud, and 3D Bioprinter
- Strategy to Lead Global Market with a Secure AI-driven Organ Regeneration Platform

ROKIT Healthcare (KOSDAQ 376900, CEO Seokhwan You), a company specializing in hyper-personalized AI organ regeneration platforms, announced that its "AI-driven Organ Regeneration Platform" has successfully completed cybersecurity technical verification by TÜV SÜD, a global testing and certification organization.

This security verification is significant as it goes beyond simple functional and performance evaluations. It officially validates, according to international standards, the security level of a high-difficulty converged medical system that combines medical AI, cloud computing, and bioprinters. As a result, the platform is expected to establish itself as a premium medical solution free from concerns regarding medical data breaches.

Recently, the U.S. FDA and the European Union (EU) have been strictly enforcing requirements for security updates and threat response systems throughout the entire product lifecycle, extending beyond the initial medical device licensing stage.

ROKIT Healthcare’s platform already meets global licensing requirements, such as U.S. FDA and European CE (MDR) standards, and is currently being commercialized in medical fields worldwide. In addition to these achievements, the company has now passed rigorous verification covering the entire process of product development, operation, and updates based on IEC 81001-5-1, the international standard for medical cybersecurity.

A company official emphasized, "This is a strategic choice to build a platform that preemptively exceeds the security levels required by global regulatory authorities, rather than merely maintaining sales qualifications. This domain will serve as a qualitative barrier to entry that competitors will find difficult to bridge in the short term."

The verification covered the entire integrated platform, where the AI-driven organ regeneration app (AiD Regen), bio 3D printers (Dr. INVIVO 4D2D / APLICOR 3D), and cloud-based data and operating systems are organically connected.

The official added, "This certification serves as core infrastructure supporting 'future revenue and growth potential' in the AI digital healthcare market. By exceeding the high security criteria of large hospitals and global medical institutions, we aim to grow into the global standard for AI organ regeneration platforms."