Evidence partners · For regulatory consultants
You take a device from strategy to certificate and keep it compliant after. Two parts of an AI file sit outside a consultancy: an independent test of the model, and monitoring of how it performs in use. creiamo.ai does both, to a public method, and signs the evidence. You keep the client, the consulting and the technical file.
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An AI lab, not a consultancy.
We are an evidence and testing lab for AI in healthcare.
We test robustness, subgroup performance and drift, including generative and agentic components, and after certification we monitor performance in use. Every report is signed and dated.
We are not a consultancy.
Where a client asks us for regulatory consulting, we point them to our partners.
Evidence, not records.
You and your clients already work with platforms: an eQMS, requirements and traceability tools, submission trackers, clinical data capture, complaint and vigilance systems, perhaps an AI governance tool. They don't produce independent test evidence on the model, or monitor how it performs in use. That is what we add.
Reports are written to be cited in software verification and validation, clinical and performance evaluation, risk management and post-market surveillance, under EU MDR and IVDR, the AI Act, UK MDR, FDA and Health Canada.
More AI files for your regulatory consulting.
Evidence that answers the reviewer's questions.
AI evidence is the newest part of the technical file and the part reviewers question most. A signed, dated, independent report to a public method gives your clinical and performance evaluations something to cite, and gives the reviewer less to ask.
Take the AI files with confidence.
With a lab behind you, an AI-enabled device is a file you can take on with the same confidence as any other.
Returns for partners.
Our partners benefit from two incremental revenue streams, neither of which changes your client's price:
- Enablement: the hands-on support that comes with every creiamo.ai engagement.
- Recurring revenue: from creiamo.ai's product fees for clients you introduce.
A say in the method.
The Evidence Profile method is public and open for review with the partners part of the AI Device Evidence Working Group.
You scope. We test. You file.
You tell us the route and the claims to test. We agree the test plan, run it against the model, and return the report to you and your client.
Questions partners ask.
How is this different from my eQMS vendor's partner programme?
An eQMS manages and stores your client's evidence. creiamo.ai produces independent test evidence on the AI model and monitors its performance in use.
What does it cost my client?
Early clients join through the Founding Partners Program at a discounted founding fee.
Can a report be changed if the results are poor?
No. Every report is signed and dated. A client can decline to use it. No one can alter or suppress it.