The change-control layer for medical AI
Every model update is a regulatory decision — in the US, UK, and EU at once. TamRx runs your change through the FDA, MHRA, and EU AI Act decision logic simultaneously and tells you what each regulator requires. Deterministic, cited, no source code or patient data.
Answer one question, before you ship
Every medical-AI team ships model updates. TamRx answers the question they face on every release — does this change need a new regulatory submission? — across the US, UK, and EU, in seconds.
Deterministic, not a guess
The verdict comes from regulators' published decision trees, encoded as logic — not from a model's opinion. Same inputs, same cited answer, every time. That's what makes it defensible in an audit.
Three regulators at once
One change is evaluated against the FDA, the MHRA, and the EU simultaneously — and shows where they diverge. Deterministic where a regulator publishes a flowchart; honest obligations where the framework is a process.
Zero sensitive data
TamRx works from public identifiers and categorical parameters — no source code, no model weights, no patient data. No InfoSec review and no NDA to start. A team can use it in sixty seconds.
A record you can keep
Every answer is source-cited and produces a structured record for a qualified person to review, adjust, and own — ready for your quality file. Never a black box.
From verdict to defensible record
Once the simulator flags what the FDA requires, drill into the detail: scope a change plan before you file, or walk a specific change and draft the record after you’re cleared.
PCCP Scope
What can a Predetermined Change Control Plan legally cover for your device? Tick your planned changes; see what a PCCP can pre-authorize — each answer cited to FDA guidance.
Scope a PCCP →Change Decision
Does this update need a new 510(k)? Walk the FDA’s decision logic, record your rationale at each step, and get a defensible letter-to-file draft.
Make a decision →Built for medical-AI teams shipping across the frameworks that govern them:
TamRx is independent and not affiliated with or endorsed by any regulator or competent authority. Outputs are decision-support for a qualified professional to review — not regulatory advice.
Common questions
Does my medical AI update need a new FDA 510(k)?
It depends on whether the change alters intended use, affects clinical performance, or introduces new risk. TamRx walks the FDA's own change-decision logic and tells you which route applies — new submission, letter to file, or covered by a Predetermined Change Control Plan — with the guidance cited.
What is a Predetermined Change Control Plan (PCCP)?
A PCCP is an FDA-authorized plan, included in your submission, that pre-authorizes specific future changes to an AI model so they can be implemented without a new marketing submission. TamRx scopes what a PCCP can legally cover for your device.
Does retraining my AI model require a new regulatory submission?
Retraining can be pre-authorized under a PCCP, need documentation, or require a new submission — depending on its effect on intended use and performance, and it can differ across the US, UK, and EU. TamRx evaluates the change against each regulator's decision logic.
Is TamRx a chatbot?
No. TamRx runs your change through regulators' published decision logic deterministically — the same inputs always give the same cited answer. A language model only helps interpret your inputs and draft the record; it never decides the outcome.
Does your next model update need a new submission?
Find out across the FDA, MHRA, and EU in seconds — deterministic, cited, no patient data.