SERVICES
Structured Market Entry for Healthcare AI
We support healthcare AI companies in navigating Taiwan’s healthcare system through a structured, PoC-first approach.
Our services focus on aligning product positioning, clinical integration, partnership strategy, and regulatory pathways—prior to full-scale market entry.
What We Do
PoC-First Market Entry & Partner Enablement
We structure early-stage market entry through targeted PoC design and stakeholder alignment.
This includes:
-
Identification of relevant clinical use cases
-
Alignment with hospital workflows and departments
-
Selection of appropriate local partners
-
Definition of PoC scope, objectives, and success criteria
Regulatory Strategy for AI Medical Devices (SaMD)
We support regulatory positioning and pathway planning for AI medical devices entering Taiwan.
This includes:
-
SaMD classification (vs non-SaMD determination)
-
TFDA pathway assessment
-
Alignment of intended use and claims
-
Preparation for regulatory documentation and review
SaMD Quality Management System (QMS) Enablement
We support AI medical device manufacturers in establishing and aligning QMS required for regulatory approval and sustainable deployment.
This includes:
-
QMS structure aligned with TFDA and international standards (e.g., FDA, ISO 13485)
-
Software lifecycle processes tailored for AI/ML-based systems
-
Documentation planning across design, risk management, and validation
-
Integration of clinical validation (PoC and cohort-based evaluation) into QMS processes
-
Coordination between headquarters and local regulatory requirements
How We Work
PoC-First Market Entry Pathway
A structured pathway applied consistently across all engagements:
-
Market & Regulatory Assessment
-
Clinical Use Case & PoC Alignment
-
Partner Enablement
-
TFDA Execution (when applicable)
This approach ensures disciplined, scalable, and regulatory-aligned adoption.
What We Are Not
To ensure clarity of scope:
-
We do not act as a distributor
-
We do not provide informal regulatory opinions
-
We do not guarantee TFDA approval or commercial success
Our role is to structure entry—not to replace execution by manufacturers or partners.
Who We Work With
We work with organizations seeking structured entry into Taiwan’s healthcare AI ecosystem:
-
AI medical device companies (SaMD / software vendors)
-
Distributors and commercial partners
-
Healthcare institutions exploring AI adoption
Engagement Approach
Engagements are typically initiated through exploratory discussions,
followed by structured scoping based on product maturity, clinical relevance, and regulatory considerations.
Who This Is For
-
Healthcare AI medical device and software manufacturers
-
Taiwan-based partners seeking AI medical solutions
