Confirm the route before you spend on evidence
The most expensive mistake in this work is not a failed submission. It is testing commissioned against a requirement that turned out not to apply — discovered months later, after the invoice.
- You receive A 10–15 page readiness report
- Turnaround 3–5 working days
- Commitment Fixed scope, no retainer
- Price On enquiry
What the assessment covers
Six questions, answered in writing. Nothing is left as "we will look into it" — where something genuinely cannot be settled without further information, the report says so and says what would settle it.
Intended use and claims
What the product is for, and what you want to say about it. Claims drive classification more often than the technology does, so this comes first.
Classification position
Which category the product falls into under the applicable rules, and the reasoning — written down, so it can be defended or challenged.
Applicable pathway
The route to market for your target market, and what that route expects you to produce.
Evidence and testing required
What has to be generated: bench testing, stability, substantiation, clinical evidence where it applies.
Gap analysis
The distance between what the route requires and what you currently hold, item by item.
Sequenced roadmap
What to do in what order, with the decision points where you can stop, change direction, or commit.
What we need from you
No formal dossier required. If you have documentation we will read it; if you do not, a conversation covers most of this.
- What the product is and what it is intended to do
- The claims you want to make
- Which market you are going to first
- Any testing, evidence or approvals you already hold
- Your intended launch timing, if you have one
Where the assessment can land
*If the assessment concludes that your product needs a route we do not support, the report will say so and point you to who does. That is a more useful answer than a proposal.
Tell us what you have built
Send the product, the claims you want to make and the market you are going to. We will come back on whether an assessment is the right next step — and say so if it is not.