How TamRx Works

TamRx turns a regulatory question into a structured, source-cited assessment and editable document drafts that you review and approve. This page explains each step of that workflow and where your judgement fits in.

Version: 1.0
Effective: 28 June 2026
Last reviewed: 28 June 2026
Owner: TamRx Ltd — Product

1. The workflow

TamRx is a regulatory intelligence workbench, not a chatbot. It follows a consistent, transparent workflow designed so that a qualified person stays in control of every output. The steps below describe that workflow from question to export.

You describe the situation

You either open a workflow or describe your device, software or regulatory challenge in your own words. The Service is designed to work from de-identified, product- and device-level information — not identifiable patient data.

Classification

Your question is classified into the relevant regulatory workflow — for example device qualification, AI Act high-risk determination, classification under MDR Rule 11, or clinical evaluation. This decides which reasoning and evidence apply.

Regulatory reasoning

The Regulatory Transition Network reasons along the consequences of your situation, drawing on a curated, reviewed knowledge structure. It identifies the regulatory impact, the documents affected, the evidence expected and the reviewer perspectives that matter.

Document generation

Where relevant, the Service drafts structured regulatory documents and internal memos, with placeholders for the facts only you can supply. These are first drafts intended to accelerate, not replace, your work.

Your review

You review the assessment and drafts against primary sources and your own qualified judgement. The output cites primary legislation and guidance, and is structured so it can be checked rather than taken on trust.

Export

Once reviewed, you can export a professional assessment, including an executive summary, classification, reviewer concerns, evidence and draft documents, for use within your own regulatory process.

2. Where your judgement fits

The Service is decision-support software. It structures regulatory reasoning and produces drafts, but it does not make regulatory decisions for you and does not provide legal, medical or regulatory advice. The review step is not optional: every output is intended to be checked and approved by a competent person before it is relied upon or submitted. Our AI Transparency Statement explains the limitations of the AI components in detail.

3. What you keep

You retain your inputs and the document drafts you generate for your own use. We process your information to provide and improve the Service as described in our Privacy Policy, and we do not use your inputs to train TamRx’s own models.

4. Getting help

If you would like a walkthrough, have a question about a result, or want to discuss how TamRx fits your regulatory process, see Contact & Support.