TamRx · Medical AI compliance
What will regulators ask me about my Medical AI?
The cheapest deficiency is the one you answer before it's asked. TamRx simulates how FDA, MHRA, MDR and AI Act reviewers each reason — they have different instincts — so you can pre-empt their concerns.
Run this assessment free →Four reviewers, four instincts
An FDA reviewer focuses on predicate logic and locked-set evidence; an MHRA reviewer on intended-purpose precision and UK routing; an MDR/Notified Body reviewer on clinical-evidence sufficiency; an AI Act reviewer on data governance and human oversight. Evidence sufficient for one is not automatically sufficient for another.
Frequently asked questions
How do FDA and Notified Body reviewers differ?
The FDA centres on substantial equivalence, predicates and locked-test-set performance; a Notified Body centres on clinical evidence sufficiency and GSPR conformity under MDR. The same file can satisfy one and not the other.
What does an AI Act reviewer look for?
Primarily the high-risk obligations: data governance quality (Article 10), human oversight design (Article 14), logging, transparency and robustness — evidenced, not assumed from MDR work.
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.