Fixed-scope engagement · Regulatory Pathway Sprint

Know your regulatory route, your evidence gaps and your timeline in three weeks.

A focused sprint that maps how your product is likely to be classified in the UK, EU and US, what evidence each route will require, and how long it will realistically take. Led by a director who has taken AI medical products through both CE marking and FDA clearance.

Discuss a Regulatory Pathway Sprint →
Duration
Three weeks
Fee
Fixed, agreed before we start
Who
Marc Goldfinger, PhD
Why it matters

Your regulatory pathway is a product decision, a budget decision and a fundraising decision at the same time. A claim made casually in a pitch deck can move a product into a higher risk class and add a year to the timeline.

Many founders find this out late: after the product is built, after the evidence plan is fixed, or in the middle of due diligence when an investor asks a question nobody on the team can answer with confidence.

The Regulatory Pathway Sprint answers those questions early, and in a form you can use with your team, your board and your investors.

What you get

Written, specific, and yours to keep.

Classification assessment

How your intended use is likely to be classified under EU MDR or IVDR, UKCA and FDA rules, and how wording choices change that.

Pathway options

The realistic routes in each market, for example 510(k), De Novo or PMA in the US, with the trade-offs in time, cost and evidence.

Evidence gap analysis

What clinical, analytical and software validation evidence each route needs, compared with what you already have.

Timeline and milestones

A sequenced plan that lines regulatory milestones up with your product roadmap and your next funding round.

Investor-ready regulatory narrative

A clear summary of your pathway for your deck and data room, written the way a specialist healthtech investor expects to see it.

How it works

Three weeks, three steps.

01
Intake

You share your product description, intended use, current evidence and target markets. We clarify anything unclear in a short working session.

02
Analysis

We assess classification, compare pathway options, and map your evidence against what each route requires.

03
Plan and debrief

We walk you and your team through the pathway, the gaps and the timeline, and hand over the written plan and investor narrative.

Who this is for
  • Medtech, diagnostics and digital health startups before or during product development
  • Founders building AI or software as a medical device who need to understand the EU AI Act alongside MDR or IVDR
  • Teams preparing to raise who need a credible regulatory story for investors
  • Companies planning to enter the US, EU or UK markets and weighing which to pursue first

Not the right fit: companies that need a formal regulatory submission prepared and filed. We will help you scope that work and prepare for it with the right specialists.

GoldWhite provides strategic regulatory advisory. We are not a notified body or approved body, and the sprint does not replace formal conformity assessment. Where specialist regulatory, legal or notified-body services are needed, we will say so and help you engage them.

If the review shows you need more support, we will say so and propose a scope. If it shows you do not, we will say that too. Either way, what we deliver is yours. See our full regulatory support.

Start with a 30-minute call.

We will confirm the Regulatory Pathway Sprint is the right fit for where you are, agree the scope, and give you a fixed fee in writing before any work begins.

Book a Call →