The global medical AI market is growing at an unprecedented pace.
As adoption accelerates, the center of competition is shifting—from algorithmic performance alone to global regulatory readiness.
For medical AI companies, regulation is no longer a post-market requirement.
It has become the starting point of product strategy and a critical driver of scalable market expansion.
In this evolving landscape, Coreline Soft has taken a distinctive path—redefining regulation not as a barrier, but as a proactive competitive advantage.
1. Designing Regulatory Strategy Before Development
In a recent interview with Medical Newspaper,
Hyei Park, Head of Regulatory Innovation at Coreline Soft, articulated a clear philosophy:
“Regulations are inevitable. Preparing earlier and more systematically is ultimately the fastest way forward.”
Over the past 18 months, Coreline Soft conducted a comprehensive review of regulatory requirements across approximately 20 countries and more than 40 regulatory units, completing a large-scale update of its flagship AVIEW platform.
Rather than avoiding tightening global standards for AI medical devices, the company chose a direct approach.
The regulatory data, experience, and internal know-how accumulated during this process have now become a formidable market entry barrier—one that competitors cannot easily replicate.
2. The Strategic Formation of the Regulatory Innovation Office
One of the most significant organizational changes at Coreline Soft was the establishment of the Regulatory Innovation Office, integrating the former Regulatory Affairs (RA) team with the Clinical team.
This decision reflects a fundamental shift in perspective.
Regulatory approval is no longer viewed as a final checkpoint after development, but as a Total Product Life Cycle (TPLC) strategy, spanning:
·
Early design: Embedding regulatory requirements into product architecture
·
Execution: Parallel operation of clinical validation and regulatory preparation
·
Scalability: Agile response to country-specific regulatory changes
By aligning regulatory and clinical expertise under a single organizational structure, Coreline Soft ensures consistency, speed, and resilience across global markets.
3. Turning Individual Expertise into Organizational Systems
Looking ahead to 2026, the company’s strategic keyword is “System.”
Relying on individual expertise may work at an early stage—but it does not scale globally.
Coreline Soft is standardizing regulatory workflows so that the same level of quality can be delivered regardless of who is responsible.
This approach transforms regulatory capability from a person-dependent function into an organizational asset—enabling global expansion through repeatable structures and processes, rather than linear increases in manpower.
Designing Trust, Not Just Technology
In medical AI, regulation represents far more than legal compliance. It is the foundation of patient safety and clinical trust.
By interpreting and anticipating global regulatory frameworks ahead of the curve, Coreline Soft positions itself not only as a technology provider, but as a company that designs trust into medical AI infrastructure.
As regulatory expectations continue to evolve worldwide, Coreline Soft remains committed to shaping—and leading—the standards that define the future of medical AI.
Source
Based on an interview with Medical Newspaper Korea
“Coreline Soft’s Global AI Leadership: Turning Regulatory Barriers into Advantage” (Jan 23, 2026 | Reporter: In-gyu Oh)
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