Paid diagnostic · two weeks · fixed fee

A written route before you spend anything

Two weeks after you send us the device, you get a document that tells you what each market actually requires, what the whole thing costs including official fees, what is missing from your file — and whether it is worth doing at all this year.

Start an assessment
£1,450fixed fee, one product family, up to two markets
14 daysfrom kickoff call to delivered document
Creditedin full against the project fee if you proceed
No retainerno obligation to continue, no auto-renewal
Why we charge for it

Because a free audit is worth what you pay for it

Everyone in this market offers a free consultation. What you get is forty minutes of generalities and a proposal. The reason is simple: nobody can afford to do real work for free, so the free version contains no real work.

The assessment is real work. Someone reads your technical file, checks the current requirements against the regulator's own publications, prices the route line by line and talks to representatives in the market. That takes days, and it produces something you can use even if you never hire us again — including, quite often, the conclusion that a different market should come first.

It is also how we qualify you, honestly. A company that will not spend £1,450 to find out what a £20,000 project involves is not going to enjoy the project. Both sides find that out cheaply, in two weeks, instead of expensively, in six months.

The deliverable

What the document contains

Between eighteen and thirty pages depending on how many markets and how complicated the classification is. Written to be read by your regulatory lead and understood by your finance director.

Route assessment — contentsTypical structure
  1. Classification opinion

    Your device against each regulator's own classification rules, with the rationale written out and the borderline calls flagged. Where two rules could apply, we say which one we would defend and why.

  2. What applies to you

    The specific requirements, guidance documents and versions in force for your class in each market — cited by document number, not paraphrased.

  3. Gap list against your existing file

    Line by line: what you already hold that will be accepted, what needs reformatting, what needs translating, and what does not exist yet. This is usually the section clients photograph and send to their QA lead.

  4. Representation model

    Whether the representative should be independent of your distributor in this market, what the exclusivity rules do to your options, and a shortlist of candidates with what each would charge.

  5. Full cost model

    Official fees, representative licence, translation and legalisation, testing if required, and our fee — separated, so you can see what is ours and what is the government's. No percentages of your revenue anywhere.

  6. Sequenced timeline

    What has to happen before what, where the dependencies bite, and where the official published review period is realistic versus optimistic.

  7. The verdict

    Our recommendation on order and timing — including when it is "not this market, not this year." We have written that section more than once, and clients have come back with the market that was right.

  8. Sources and dates

    Every figure traced to the regulator's publication and the date we checked it. Where a rule is unpublished or in flux, we say so rather than quoting a number from a consultancy blog.

You get it as a PDF plus a one-hour call to go through it. The cost model comes as a spreadsheet you can drop into your own planning.

How it runs

Fourteen days, and what happens in them

  1. Day 0

    Kickoff call, 45 minutes

    Your device, your commercial plan for the market, what you already hold, who you are already talking to locally. We send the document request the same day.

  2. Days 1–4

    File review

    We read what you sent against the regulator's requirements and build the gap list. Most questions we have for you arrive in this window, in one batch rather than one at a time.

  3. Days 5–9

    Verification and quotes

    Requirements re-checked against current publications, and representative candidates approached for real quotes rather than estimates. This is the part that cannot be done from a template.

  4. Days 10–12

    Drafting

    Cost model built, timeline sequenced, verdict written. If the answer is going to be uncomfortable, you hear it by phone before you read it in a document.

  5. Day 14

    Delivery and review call

    Document, spreadsheet and an hour to argue with it. You own the output, including if you take it to another provider.

What slows it down: almost always the document request. If your technical file is with a consultant who is slow to release it, tell us at the kickoff call and we will plan around it rather than promising fourteen days we cannot hold.

Fit

Who this is for, and who it is not

Worth doing if

  • You hold CE, UKCA or FDA clearance and are deciding where to go next
  • A distributor in the region has approached you and you want to know what you would be signing
  • You have been quoted wildly different numbers by two providers and want a third view with sources
  • Your board has asked for a costed plan and you need something defensible
  • You suspect your existing registration is held in the wrong name and want to know how bad it is

Not yet, if

  • The device has no technical file and no approval anywhere — start at home
  • You want a guaranteed approval date. Nobody can give you one, and anyone who does is selling something else
  • You are looking for a distributor rather than a registration. We do not do that, and we will tell you so on the call
  • You need it in three days. We would rather decline than deliver something we have not verified
Cost

What it costs and what it becomes

Route assessment

£1,450

Fixed. One product family, up to two markets.

  • Kickoff and review calls included
  • Document, cost model and source list
  • Additional market: £600
  • Additional product family: quoted after the call

If you proceed

Credited

The full £1,450 comes off the registration project fee, which runs £12,000–25,000 per product family per market.

  • Official fees always billed at cost, with the receipt
  • Representative fees passed through, not marked up
  • No retainer and no minimum term on the assessment

Paid on invoice before the kickoff call. We are not currently VAT registered, so no VAT is charged.

Before the call

What we will ask you for

You do not need all of this to book. You need it to get a useful document, and part of our job is telling you which pieces you can skip.

  • Device name, intended purpose and the variants in scope
  • Your current classification and how you reached it
  • Any approvals held, and where
  • ISO 13485 certificate, if you hold one
  • Declaration of conformity
  • Technical documentation or its index
  • Current labels and instructions for use
  • Whether you already have a distributor or agent in the market
  • Your expected volumes and price point
  • Your internal deadline, if one exists

Everything you send is covered by a mutual NDA, which we will sign before you send anything. If your legal team prefers its own template, send that instead — we do not argue about NDAs.

Questions

Asked before every kickoff call

What if the answer is that we should not do it?

Then the document says so, with the reasoning, and you have saved a great deal more than £1,450. That outcome is not a failure of the assessment — it is the assessment working.

Can we use the document with another provider?

Yes. You own it outright, including the shortlist and the cost model. We would rather be chosen on the strength of the work than on you having no alternative.

Do you guarantee the fees and timelines quoted?

We guarantee they were correct at the date on the page and traced to the regulator's own publication. Fee schedules and review periods change, and when they do we tell existing clients before they read it elsewhere.

Which two markets should we pick?

Bring that question to the kickoff call. Roughly half of assessments end up covering a different pair of markets than the client first named, and that conversation costs nothing.

Start

Send us the device and the markets

Reply by email with the device, its class and the markets you are weighing, and you will have a time for the kickoff call the same working day. If it is easier, WhatsApp works — a lot of our conversations with the Gulf happen there.

Fields for the enquiry form

  • Name and company
  • Work email and phone
  • Device or product family
  • Markets under consideration — multiple choice from the six
  • Approvals already held — CE, UKCA, FDA, other, none
  • Anything we should know before the call — free text
  • Consent checkbox with a link to the privacy notice

Two weeks from now you could know

What applies, what it costs, what is missing and whether it is worth doing. In writing, with sources, for a fixed fee.

Email us the device

mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp