Regulatory Strategy Workshop
You want to bring a medical device to market under the EU MDR? Let’s talk about how you can get it done.
We’ll sit down with you for two hours in a video call, answer all your questions and lay out a plan: timeline, costs, and next steps.
400€ (+ 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 prototype is enough. We then:
- Clarify your device’s MDR class and feasibility of 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 & 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
- All your questions answered: Bring your toughest regulatory questions - we’ll tackle them one by one until everything is clear.
- Clear action plan: Know the exact next steps, timeline, and cost to reach the market.
- MDR classification: We assess your product and confirm its medical‑device class under the MDR.
- Class I strategy check: Class I can save time and money - let’s see if your device qualifies.
- Notified body selection: Get a shortlist of the most suitable notified bodies for your device.
- Save consultant costs: Our guidance helps you avoid the typical 50k€+ consultant spend.
- Regulatory automation & ChatGPT: Learn tools and prompts to generate documentation faster and cheaper.
Frequently asked questions
Nope! It’s helpful if we can see a demo or screenshots of your product, but a verbal description works too.
Because we love helping startups - and we believe great regulatory advice should be accessible.
You’ll receive an invoice after the workshop and can pay via bank transfer.
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?
Book a free introductory call or chat with us - no strings attached.
Got questions? Reach out any time - we’re happy to help!