TamRx · Medical AI compliance
Build my Medical AI regulatory strategy
A regulatory strategy is a sequence of decisions, and the three regulators apply parallel but non-identical logic. TamRx maps your claim against each, shows where they diverge, and identifies the evidence you still need.
Run this assessment free →From idea to submission
A strong strategy fixes the intended purpose, classifies across jurisdictions, maps the evidence you hold against the evidence each regulator expects, and sequences markets so evidence reuse is maximised and contradictions avoided.
Frequently asked questions
Should I go to the FDA or CE/UKCA first?
It depends on your market priority, evidence and predicate availability. Strategy is about sequencing so evidence transfers where possible — though evidence sufficient for one jurisdiction is not automatically sufficient for another.
Does FDA clearance help with a Notified Body?
It can support your case but does not automatically satisfy MDR. The clinical evidence and GSPR conformity a Notified Body expects must be demonstrated on their terms.
Related
Decision-support only. AI-generated content may contain errors. Not legal or medical advice, and no guarantee of regulatory approval. Verify against primary legislation, guidance and qualified professional judgement before submission.