Sector · NHS · MHRA · EU MDR
AI clinicians can use without breaking AI-SaMD rules
Healthcare clients use Exec × AI when AI sits inside a clinical pathway and the MHRA, the EMA or the FDA is the audience.
MHRA · EMA · FDA
How the sector reads
You will see the regulatory route mapped on day one (Class IIa, IIb or III), the conformity-assessment body shortlisted and the clinical-evidence file scoped to the device class.
Dr Maliha Javed leads sector work and is the named principal on every healthcare engagement. Patient safety is sized in the first risk file, not the last.
Where the deployment does not need AI to deliver the clinical benefit, we say so. Most pilot programmes we have audited carried at least one feature that did not need a model.