You have the business idea, the product, the market analysis and the strategy. What most founders and teams are missing is the answer to one critical question: what
is the fastest, most realistic path to market, and what will it actually cost?
The biggest showstopper in MedTech and life science is not the technology, it is discovering too late that you have no clear picture of your regulatory requirements, no cost estimate, and no route map. Investors ask for it. Boards need it. And without it, your launch timeline is a guess. This service gives you that picture in one structured workshop.
FIXED PRICE - ONE ENGAGEMENT
Regulatory Navigation Workshop
Base Price: 24 900 kr (excl. VAT Full engagement)
What is Included?
- Pre-workshop intake & product review
- Structured workshop with a Yallow regulatory expert (4 hrs)
- Introduction to the Quality Management System and the company’s requirements
- Product & market regulatory mapping
- Technical documentation requirements overview
- Production & supply chain compliance requirements
- Regulatory pathway recommendation (EU / FDA / other)
- Cost-to-market estimation
- PowerPoint deliverable, your regulatory roadmap
- 30-day follow-up Q&A session
Who is this for?
Founders, product teams, Quality Managers, Regulatory managers, PRRC and investors who need to understand the regulatory landscape for their product before committing significant resources.
THE CHALLENGE
Where most teams hit the wall & when?
The regulatory gap is rarely discovered at ideation. It surfaces when it is most expensive to fix.
01) Business Idea & Product Concept
You have a clear product, a market, a business model, and a team. Everything points to potential.
02) Strategy & market analysis
Market sizing, competitive landscape, go-to-market strategy and early investor conversations are underway.
03) Regulatory Reality Check
No one on the team has mapped the regulatory requirements. Classification, QMS obligations, technical documentation, timelines, and costs are all unknown, and investors are asking.
04) Clear path to market
One workshop. One deliverable. You leave with a defined regulatory pathway, a QMS plan, a cost estimate, and the confidence to move forward.
HOW IT WORKS?
One Workshop. Three Outcomes.
The Regulatory Navigation engagement is structured around a single focused workshop session, designed to extract what you know and translate it into what you
need.
STEP 01 - BEFORE
Intake & Allignment
We review your product concept, intended use, target markets, and business strategy before the workshop. You complete a short intake brief, so we arrive prepared, not learning on your time.
STEP 02 - WORKSHOP DAY
Navigating Together
A structured session with a Yallow regulatory expert. We align on your product, map the regulatory landscape, assess QMS and technical documentation requirements, and identify the shortest compliant route to your target market. We might have few short meetings to align the concept, idea, product and regulatory pathway.
STEP 03- AFTER WORKSHOP
Your Deliverable
Within 10 business days you receive a PowerPoint presentation defining your product's regulatory classification, QMS requirements, technical documentation scope, production requirements, recommended pathway, and a rough cost-to-market estimate.
WHAT YOU GET?
Powerpoint Presentation
All of the above in a clean, professional slide deck ready for your board, your investors, or your internal team. Yours to keep and use without restriction.
GET STARTED
Book the workshop
Tell us about your product and company and we will confirm your booking one response, within one business day.