01Claim-to-Evidence Audit
We map every clinical and performance claim a product makes to the evidence behind it, and show exactly where the evidence stops.
HealthEach stated clinical benefit traced to its supporting data and its gaps, read against the evidence expectations FDA and CE-Mark reviewers apply to Software as a Medical Device (SaMD).
PerformanceEach performance claim traced to whether it was ever validated in the population that uses it.
OutcomeYou know which claims you can stand behind and which expose you.
02Integration Audit
We test whether the technology holds up inside the real decisions it is meant to inform, not just on the bench.
HealthClinical safety and adoption framing. An invalid measurement is an unlogged hazard under medical device risk management (DCB0129/ISO 14971), and we treat it as one. This is also the evidence the NHS adoption gates ask for: NICE Evidence Standards Framework tiering and DTAC.
PerformanceDecision-fit framing. Whether the output is good enough to drive the training or selection call it is being used for.
OutcomeYou know whether the technology is safe and fit to act on in practice.
03Technical and Clinical Due Diligence
An independent read on whether a technology and its evidence stand up, for the people committing money.
HealthFor investors and acquirers assessing a clinical product before they commit, including whether the evidence base can carry the SaMD regulatory pathway (FDA or CE-Mark) the business case assumes.
PerformanceFor teams and funds assessing a performance product before they buy or back it.
OutcomeA clear verdict on technical and evidential risk before capital is at stake.
04Validation Study Design and Analysis
We design and run the study that builds the evidence the product is missing.
HealthProtocol, analysis and reporting to a standard that survives regulatory and clinical scrutiny, including Software as a Medical Device (SaMD) evidence generation aligned to FDA and CE-Mark requirements.
PerformanceField-valid study design that tests the device where it is actually used.
OutcomeThe evidence base the product needed and did not have.
05Technical and Product Advisory
Ongoing advisory for the teams building the technology: measurement, algorithm, and product decisions, on a retainer rather than a single deliverable.
HealthMeasurement and algorithm decisions for clinical products, including what the evidence base has to carry if the Software as a Medical Device (SaMD) pathway is the one the business case assumes.
PerformanceMetric selection, derivation, and interpretation for products and deployments in elite sport, defence, and other high-performance settings.
OutcomeMeasurement decisions made with the evidence in the room, rather than reconstructed afterwards.