CLARIFI.FI

The Clarifi System

Clarifi is building a structured approach to early-stage regulatory decision-making — helping founders understand classification, pathway, and risk early.> Navigator Modules (In Development)
• Classification Navigator
• Pathway Mapping Framework
• Evidence & Risk Mapping> Decision Support Layer> Translation Layer

CLARIFI.FI

Who We Work With

Clarifi is designed for founders building in regulated environments — where early decisions shape the entire business.

CLARIFI.FI

About

Clarifi was founded by Stephen O’Rourke, a regulatory strategist working at the intersection of MedTech, FoodTech, and emerging digital regulation.His work focuses on structuring regulatory decision-making early — translating complex frameworks into usable systems that founders can actually use.Before founding Clarifi, Stephen held Regulatory & Compliance responsibilities at Infinite Roots, contributing to regulatory strategy and evidence planning during the company’s €50M Series B.He is also selected as an external evaluator for the European Commission’s Health and Digital Executive Agency (HaDEA), providing insight into how innovation is assessed at EU level.Alongside Clarifi, he contributes to selected policy and advocacy work in areas such as patient safety, food innovation, and regulatory transparency — applying regulatory thinking beyond compliance into real-world impact.

Selected Media & Insights

Interviews and features on regulation, innovation, and startup strategy.Recent appearances include speaking at the Dubai International Food Safety Conference (2025).1. Startups don’t just need tech leads: They need an integrator.
Feature for EU-Startups2. Confidential by Default? The Transparency Dilemma in Europe’s Novel Foods System.
Feature for Green Queen Media3. Digital Health Meets Red Tape: What Pharma Can Learn from Software as a Medical Device
Feature for PharmaNow4. Lessons from a €50 million Series B: And why it matters at every startup funding stage
Feature for EU-Startups5. Guest article: EU novel food delays. Why bureaucracy is choking off food innovation
Feature for AgFunder NewsContact: info(at)clarifi.fi
For interviews, collaborations, or speaking invitations.

How Founders Use Clarifi

1. Run the Regulatory Readiness Test2. Identify pathway & risks3. Apply structured guidanceNot sure where you stand yet? ↓

• Start with the Regulatory Readiness Test

What We Are Building

Clarifi is developing a set of lightweight regulatory navigation tools designed for early-stage founders.These tools help answer:• What am I building (regulatory classification)?
• What pathway am I entering?
• What risks am I creating early?The goal is to make regulatory understandable, actionable, and eventually productised.

Contact

Whether you’re refining a submission, mapping your regulatory pathway, or simply trying to make sense of the rules, feel free to get in touch.Clarifi offers focused conversations that turn uncertainty into clear next steps.Use the contact form below to share a few lines about your project, and I’ll get back to you within 1–2 business days.