For Regulatory & Legal Teams

Your AI product is cleared.
Can you prove it is governed?

Health system IT review is where medtech AI deals stall. Darwin is the governance documentation package that gets them moving. Pre-built, independently verified, and structured for the questions procurement will ask.

The Procurement Gap
IT review is not a technology problem. It is a governance documentation problem.

A medtech company with a cleared AI product faces a long health system IT review. Most of that time is not spent evaluating the product. It is spent waiting for governance documentation the vendor has not produced in the format the health system requires.

That documentation exists pre-built, structured against ten governance frameworks, independently verified, and formatted for the questions a health system CISO, GC, and board audit committee will ask. The IT review conversation changes from “we need to evaluate your governance” to “we have reviewed your governance.”

Before Darwin
health system IT review cycle
Procurement stalls waiting for governance documentation assembled under pressure, formatted differently for each health system, and not independently verified by any third party.
With Darwin
Pre-built governance package, independently verified
RAISE 4.0 Strong behavioral score. Ten-framework evaluation. Sealed TVS record. Structured for CISO, GC, and board review. Available before the IT review conversation begins.
What Darwin Produces for Your Product

A TVS score across six dimensions.
A sealed record the health system trusts.

Your AI product is assessed against the six TIPPSS dimensions defined in IEEE UL 2933. The result is a sealed TVS record: tamper-evident, formatted for governance review, and owned by the organization that commissioned it.

For the CISO
OWASP Agentic AI alignment, agent identity and permission boundaries, behavioral verification evidence. The security governance documentation package procurement requires.
For the GC
Sealed, tamper-evident governance record. Independent of vendor self-declaration. Structured for discovery and regulatory review. Ready before a question is asked.
For the Board
Maturity level designation. D&O carrier alignment. Fiduciary oversight documentation. The governance artifact the board audit committee needs before AI tools touch patient care.
If Your Product Receives a Conditional Result
A conditional score is not a rejection. It is a remediation roadmap.

Darwin tells your team exactly which dimension failed and what closing that gap requires. A Conditional 90 or Conditional 60 designation means the path to Approved is documented, tracked, and sealed.

That remediation path is also what a health system needs to justify continued deployment while improvement is underway. Darwin gives both sides the evidence they need.

4.0+
Approved
Cleared for governed deployment.
3.0–3.9
Conditional 90
Remediation roadmap. 90-day window.
2.0–2.9
Conditional 60
Material gaps. 60-day window.
<2.0
Rejected
Deployment blocked. Sealed rejection record.

Bring us the AI product you are trying to get into health systems.

Darwin will assess it, create a sealed TVS record, and tell you exactly where you stand before the IT review conversation begins. The result is yours to show procurement.

Start the Conversation See the Evidence