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TamRx
Regulatory intelligence infrastructure

What happens to your regulatory obligations when your AI changes?

TamRx is a regulatory intelligence platform for AI in life sciences. It helps medical device, healthcare-AI and pharmaceutical teams understand the regulatory consequences of every AI lifecycle change — across the EU AI Act, MDR, IVDR, MHRA and FDA.

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The platform

A regulatory workbench, not a chatbot

TamRx reasons through regulatory questions the way an experienced regulatory affairs professional would — structured, evidence-led, and honest about uncertainty.

Change → consequence

TamRx is built around the question generic tools answer worst: what a specific AI lifecycle change actually triggers across your obligations.

Four-framework reasoning

Every assessment is reasoned across the EU AI Act, MDR and IVDR, the MHRA regime and the FDA — and shows where they diverge.

Reviewer simulation

Anticipate what FDA, MHRA, notified body and AI Act reviewers are likely to ask, before they ask it.

Structured & reviewable

Output is consistent, source-cited and designed for a qualified person to review, adjust and own — never a black box.

Start with your question

Begin with the question you’re already asking

Each starts a structured assessment — classified, reasoned along the regulatory consequence graph, and pressure-tested against the relevant reviewers. Not a chatbot: a regulatory workbench.

Medical devices & healthcare AI
Does retraining my medical device AI change my MDR obligations?Does model drift affect my AI Act compliance?Does changing my training data require updating technical documentation?Does updating my AI model require a new clinical evaluation?Could this AI update count as a significant regulatory change?Does this AI change affect post-market surveillance?Is my software considered a medical device?Is my medical AI classified as high-risk under the AI Act?
Pharmaceutical AI
Does retraining an AI model require an EMA variation?Does fine-tuning a GxP AI system affect regulatory compliance?Could changing the foundation model invalidate my validated AI workflow?Do AI model updates require new validation documentation?

Built for organisations working across the frameworks that govern medical AI:

EU AI ActEU MDRIVDRMHRAFDA

TamRx is independent and not affiliated with or endorsed by any regulator or competent authority.

FAQ

Common questions

Is my AI a medical device?

Whether your AI software is regulated depends on its intended purpose and whether its output informs a clinical decision, not on the technology itself. TamRx assesses this across the EU MDR, MHRA and FDA frameworks.

Is my medical AI high-risk under the EU AI Act?

If your AI is a CE-marked medical device regulated under the MDR or IVDR with notified body involvement, it is automatically high-risk under the EU AI Act. TamRx determines this and maps the resulting obligations and timeline.

Does retraining my AI change my regulatory obligations?

Retraining can trigger a significant change, a new clinical evaluation, or fall within an authorised change-control plan, depending on its effect on intended use and performance. TamRx traces these consequences across the relevant frameworks.

Is TamRx a chatbot?

No. TamRx is a regulatory intelligence workbench. It classifies each question, reasons along a curated regulatory consequence structure, simulates reviewer perspectives, and returns a structured, reviewable assessment — not a free-form chat response.

Understand your regulatory exposure before it surprises you

See what changes when your AI changes — across the AI Act, MDR, MHRA and FDA.

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