🧠 You Don’t Need a Regulatory Consultant (Yet)

Welcome to the first issue of RegulatoryStory.

If you’ve followed my posts on LinkedIn, you’ll know I’ve spent the past few years sharing insights, frustrations, and practical advice around regulatory strategy — especially where good teams get stuck in bad systems.

From EU MDR delays to FDA grey zones to the endless unknowns of EFSA’s novel food process, I’ve seen how startups in MedTech, biotech, and foodtech all run into the same problem:

Regulation that’s critical to your product — but nearly impossible to decode without a scientific translator or +€20K consultant.

So now, I’m going one step further.

RegulatoryStory is a space I’ve created to go deeper — to break down regulatory complexity in a format that’s accessible, practical, and built for the people who actually need to work with regulation:

→ Founders

→ Product teams

→ Commercial leads

→ Early RA/QA hires

→ Operators doing a bit of everything

Whether you’re trying to CE mark a device, get a 510(k) through the FDA, or understand if your food ingredient qualifies as novel food — this newsletter is for you.

It’s here to help you avoid costly missteps, speak the language of compliance (without needing to be fluent), and build with more clarity and confidence.

Let’s get into Issue #1.

> The Big Idea: The Consulting Trap

Most startups hire a regulatory consultant way too early.

They panic. Or they’re told by investors: “Get a CE mark sorted.”

So they call a consultant, spend €10–20K, and… end up with vague advice, copy-and-paste Word Docs and PDFs, or expensive slide decks they don’t understand.

Why does this happen?

Because if you don’t know what you actually need help with, no consultant can help efficiently. It’s like hiring a lawyer before knowing what you’re being sued for.

> The 1-Hour Reg Strategy Sprint

Before you spend anything, sit down and answer these three questions (of course, you’ll already know if your company is dealing with medical devices or novel foods!):

1. What exactly is our product — legally?

   (Is it a medical device? A food? A software? Something else?)

2. Where do we want to launch in the next 12–24 months?

   (EU? US? Both? Elsewhere?)

3. Do we know the general regulatory pathway?

   (Class IIa under MDR? 510(k)? EFSA novel food? Unsure?)

✅ Write this down.

It becomes your Regulatory Positioning Brief — a 1-page sanity check that aligns your team and saves you thousands.

> Real Mistake I’ve Seen

A startup I worked with spent €14,000 building a full ISO 13485 Quality Management System.

But they didn’t even have a working prototype.

Six months later:

No CE mark. No revenue. But plenty of SOPs they didn’t need (yet).

Lesson: Infrastructure without clarity = waste.

> What I’m Reading

Why EU MDR Is Crushing Innovation – Sifted

This piece highlights how broken the EU system feels to founders — and why regulatory reform matters. But until it changes, we can at least help each other navigate it smarter.

> What’s Your Biggest Regulatory Headache?

Reply to this email and tell me.

I’ll pick one to answer in the next issue — anonymously if you prefer.

—

Stephen

Founder, RegulatoryStory

Compliance, without the confusion.

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