Evidence Review, Essential
What your evidence currently supports, and what it does not.
Assessment of the claim you intend to make against the evidence you hold. Three layers: whether the instrument measures what it claims, whether the derived output is valid, and whether the claim is reachable from either. Written findings, scored 1-10 per layer.
For companies who need to know where they stand before deciding what to build.
Evidence Review, Standard
The Essential review, plus regulatory position and comparison against the field.
Adds the position of the intended claim against the wellness to SaMD boundary, with the specific wording that holds the classification and the wording that breaks it. Adds benchmarking against comparable products and the evidence they hold. Adds a prioritised evidence gap list, sequenced to launch.
For companies approaching launch, a raise, or a regulatory decision.
Essential answers “is this true”. Standard answers “can we say it, and is it enough”.
Evidence Review, Full
The evidence position and a costed path to closing it, in one engagement.
Standard, plus a human-factors gap analysis against IEC 62366-1 and AAMI HE75, workflow risk hypotheses for real-world use, a costed remediation plan, and a 60-minute leadership briefing call. The claim-to-evidence method is unchanged from Essential and Standard: the added scope sits around it, not inside it.
For companies who need the evidence position and a costed path to closing it in one engagement, typically ahead of a raise or a board decision.
Standard answers “can we say it, and is it enough”. Full adds “and here is what it will cost to fix, if not”.