Why I created CSDmed, and why I admire those who dare
1. Introduction - What if the real courage was to take the plunge?
Creating an innovative medical device.
Launching a project that doesn't yet exist.
Bringing an idea to life, despite doubts, standards and obstacles.
It's an adventure.
What if I told you that it took me a long time to get started?
I spent years coaching others, without ever daring to create my own structure.
And yet I dreamed of it!
And one day, I said "go", I was 42 years old, and believe me, I was scared to death.
That's why I admire MedTech start-ups so much.
Because that's what you do: dare.
2. Fear as a companion
I used to be shy, anxious and more than a little cautious.
By dint of saying "yes" to projects, customers and opportunities, I found myself embarked on some incredible adventures.
Courage has never been a given. It has always been a decision.
"Courage is not the absence of fear. It's the ability to overcome it." Nelson Mandela
That's exactly what it is.
And I've come to understand that it's better to move forward with fear... than to stay stuck because of it.
3. Why I admire start-ups
If you're a medical device start-up, you're probably :
- working on an innovative concept,
- tinkering with a prototype,
- looking for funding,
- trying to understand what "MDR 2017/745 Annex I" means..
And with all that, you move forward.
That's real courage.
I waited 20 years. You (I don't know your age), you go for it.
I say this with all my sincerity: I deeply respect entrepreneurship.
And that's why I created CSDmed.
4. Why I launched CSDmed at the age of 42
I was an employee for a long time, then a consultant.
I had a will of steel forged by sport and my childhood struggle with powerful asthma. I had recognized technical skills, loyal customers and a clear vision... but not the courage.
It took time.
Some soul-searching.
And a little of that mixture of audacity and mild madness known as "entrepreneurship".
CSDmed was born out of my desire to do things my own way, and my sincere admiration for those who fight to bring a product, an idea or a technology to life.
Today, I have only one objective: to help those who dare.
5. What I want to do today
I want to be a partner to those who are just starting out.
Not just a service provider or regulatory expert.
A true project partner, capable of :
- guiding you through R&D from the earliest stages,
- structure your quality approach intelligently (without gasworks),
- accompany you towards realistic, well-documented CE marking,
- prepare you, if necessary, for a clear FDA strategy.
I want us to build together.
Case study 1 - An idea, a call, a start
A start-up calls me: two biomedical engineers, a working prototype, a brilliant idea.
But zero structure, zero docs, zero MDR ideas.
They thought they were "too small" to be supported.
Three months later, they had a clear plan, a launched document architecture, an aligned regulatory strategy.
They weren't too small. They were just ahead of their own success.
Case study 2 - A founder's trigger
An executive contacted me: his spin-off was paralyzed.
Too many standards, too many fears, not enough resources.
We spent half a day discussing the project.
Then a week to clarify the need, simplify the roadmap, prioritize the steps.
The result? He left with a vision. And motivation.
6. Mini FAQ
Do I need to already have a prototype to contact you?
No. I'm also involved upstream: monitoring, proof of concept, feasibility.
Do you only work with start-ups?
No, we don't. But I reserve a special place in my heart for them, because I want to see them succeed.
Do you also work in the US (FDA) or just for CE marking?
I do both. And I help you make the right choices for your target markets.
Can I have a free initial consultation?
Yes. You write to me and we talk. You don't need a quote to talk.
What makes you different from other consulting firms?
I don't sell "ready-to-sign". I really get involved. And I love what I do.
7. Courage is contagious
When I launched CSDmed, I was afraid.
When I see you launch a MedTech project, I find you admirable.
If you're at a crossroads, if you're in doubt, if you're hesitating..
Know that you're not alone. And you're already showing courage.
So if you need a partner to help you move forward, I'm here.
8. Write to me personally
Do you have an idea, a doubt, a desire to move forward?
I'll take the time to get back to you. And together we'll find a way forward.
9. Related resources
-MedTech start-ups: where to start preparing for CE marking?
-What is good regulatory support for a start-up?
-ISO 13485 for start-ups: 3 realistic approaches
Guillaume
Founder of CSDmed
I support those who dare to create a medical device.
Write to me, and we'll see together how to go further.