Services

Five ways we work.

Each runs in a health and a performance instantiation off the same framework, and none of it is a nice-to-have. An invalid measurement that reaches a decision is a hazard you are obliged to find first. The first four are scoped pieces of work with a deliverable at the end. The fifth is ongoing.

01

Claim-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.

Health

Each 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).

Performance

Each 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.

02

Integration Audit

We test whether the technology holds up inside the real decisions it is meant to inform, not just on the bench.

Health

Clinical 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.

Performance

Decision-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.

03

Technical and Clinical Due Diligence

An independent read on whether a technology and its evidence stand up, for the people committing money.

Health

For 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.

Performance

For 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.

04

Validation Study Design and Analysis

We design and run the study that builds the evidence the product is missing.

Health

Protocol, 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.

Performance

Field-valid study design that tests the device where it is actually used.

OutcomeThe evidence base the product needed and did not have.

05

Technical and Product Advisory

Ongoing advisory for the teams building the technology: measurement, algorithm, and product decisions, on a retainer rather than a single deliverable.

Health

Measurement 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.

Performance

Metric 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.

Conflicts

Where we cannot sit on both sides

Most of our work is advisory to the teams building the technology, and evaluating a product then helping improve it is a normal part of that. Two things are different. A diligence read for investors or acquirers (03) only means anything if we are not also the company's advisor, and the named Clinical Safety Officer role carries personal signed accountability. For any one company we take the advisory seat or one of those, never both, and we will tell you which one we are in before we start.

Free · entry point

Self-assessment toolkit

A free entry point. Builders and teams check their own claims against the framework before they come to us.

Coming soon
Pricing

Scoped to the work.

The first four are scoped and priced to what you need, off a short discovery call. No long contracts, no scope creep.

Technical and Product Advisory (05) works differently, because the work is ongoing rather than a single deliverable. It runs on a monthly retainer, agreed up front against the amount of time you actually want.

Discounted rates are available for the NHS, early-stage start-ups, and other mission-aligned organisations. Just ask when you enquire.

Not sure which one you need?

Start with a call. We’ll point you at the one that fits the question you actually have.