Regulatory strategy workshop.
Bringing a medical device to market under the EU MDR? Let’s talk about how you can get it done.
Two hours on a video call — we answer all your questions and lay out a plan: timeline, costs, next steps.
1,000€ (+ VAT). First intro call is free.
What is the workshop?
The Regulatory Strategy Workshop is a focused, two-hour video call with our expert team. We answer all your EU MDR questions, clarify the classification of your device, and create a realistic roadmap to market.
By the end, you’ll know exactly what to do next, how long it will take, and how much it will cost — without spending thousands on generic consulting packages.
How does it work?
We jump on a video call (your whole core team can join). You give us a quick demo of your product — screenshots or a prototype is enough. We then:
- Clarify your device’s MDR class and feasibility of a Class I strategy.
- Map out required documentation and activities.
- Suggest suitable notified bodies (if needed).
- Estimate realistic timeline and budget.
- Show how to leverage automation and ChatGPT to cut workload and consultant costs.
You receive a summary plan right after the call, so you can execute immediately.
What you’ll get
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All your questions answeredBring your toughest regulatory questions — we'll tackle them one by one until everything is clear.
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Clear action planKnow the exact next steps, timeline and cost to reach the market.
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MDR classificationWe assess your product and confirm its medical device class under the MDR.
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Class I strategy checkClass I can save time and money — let's see if your device qualifies.
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Notified body selectionGet a shortlist of the most suitable notified bodies for your device.
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Save consultant costsOur guidance helps you avoid the typical 50k€+ consultant spend.
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Regulatory automationLearn tools and prompts to generate documentation faster and cheaper.
Frequently asked questions
Do we need to prepare anything?
Nope — it's helpful if we can see a demo or screenshots of your product, but a verbal description works too.
Why is it so cheap?
Because we love helping startups, and we believe great regulatory advice should be accessible.
How can we pay?
You'll receive an invoice after the workshop and can pay via bank transfer.
Who should join from our team?
Ideally the people who influence product and technical decisions. In early-stage teams, that's usually all founders. In larger companies, bring one technical, one product, and one regulatory person.
Ready to get clarity on your MDR strategy?
Chat with a human — no strings attached.
Got questions? Reach out any time — we’re happy to help.