Most device founders write the regulatory plan for their regulatory consultant and the financial plan for their investors. Investors read them as one document. The regulatory plan decides when revenue starts, how much the first markets cost, and how far the round has to go. If those numbers are not in it, the investor fills them in, usually less kindly than you would.
Here is what an investor is looking for in it, and how to give it to them.
1. A route per market, not "FDA then CE"
"510(k) next year, then CE" is a sequence, not a plan. For each market you name, say which route you expect, why, and what it rests on: a predicate, a reference approval, a clinical study. A founder who says "comparable devices in this area went through 510(k), and here are three of them" is answering the question before it is asked.
Say it as an estimate. A route is a reading of how comparable devices were treated, not a ruling, and an investor trusts the founder who labels it that way.
2. Time and cost for each market, from your own dates
Each market needs its own line: submission date, expected review time, fees, local representation, testing and translation. Build it from your own anchor dates (when you submit, when you expect approval, when you launch) and let the work that runs during a review, such as distributor contracts, clinician relationships and reimbursement, fall before approval rather than after it. That is the difference between a plan that starts selling on approval day and one that starts looking for a distributor then.
3. The order, and what the first approval buys you
Some markets shorten their review for devices already approved by a reference regulator. Others give no credit at all. The order you choose changes the total time and cost, so show why it is this order: which approval opens which next market, and which markets you are leaving out and why.
4. Who will hold the license
In many markets a foreign manufacturer cannot hold its own registration: a local entity does. If that is your future distributor, the registration is theirs, and so is your access to the market if the relationship ends. Investors who have seen this go wrong will ask. Name the model you intend, market by market: your own entity, an independent representative, or the distributor.
5. Who is already there
Name the competitors registered in your device area in each target market, and who sells for them. An empty market is either an opportunity or a sign that the route is hard; the plan should say which, with the evidence.
6. How far the money goes
Put the phases in order, cost each one, and show where the raise runs out. Stop at the first phase you cannot price rather than guess past it. A plan that says "this round takes us through US clearance and the first two Asian filings; the third needs the next round" is one an investor can check, and that is the point.
Build the plan and the investor pack from the same data
Meridian Trace drafts a launch plan by market from over 2 million device registrations across 31 markets, then turns it into an investor pack that shows how far the raise goes. Startups have their own program.
See how it works for startups →The test
Hand your regulatory plan to someone who has never seen your deck and ask them three questions: when is the first sale, what does it cost to get there, and what happens if the first route fails? If the plan answers all three, it is a fundraising document. If it does not, the investor will ask, and it is better to have the answer written down.