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 for bringing your medical device to market, how long it will take and how much it will cost.
For only 400€ (+ VAT).
Book a free call now to learn more and get started:
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All your questions answered
Are you struggling with medical device compliance questions and how to solve them? We'll go through all your questions and answer them.
You'll have a plan for the way forward
How much will medical device compliance cost for your company? And when will you be on the market?
Get a MDR medical device classification
Not sure which class your medical device is? No worries, show us your product and we'll assess your MDR class.
MDR class I strategy
Bringing a class I device to market can be beneficial, because it's cheaper and faster. We'll take a look at whether your device could be classified as class I.
Notified Body selection
Unsure which notified body to choose? We'll help you select the best one for your company.
Save (lots) of money and consultant costs
We'll show you how you can get compliance done mostly by yourself, easily saving you 50k€+ of costs you'd otherwise spend on consultants
Regulatory automation & ChatGPT
We'll show you how to use software and ChatGPT to draft your documentation even faster, reducing your workload and costs for consultants and employees.
Frequently Asked Questions
Do we need to prepare anything?
Nope! However it’d be really helpful if we could see a demo of your product to better understand it. So, best case, you can screen share a prototype of your software or show us some screenshots. If you don’t have any yet, prepare a description!
Why is it so cheap?
Because we like helping startups 🙂
How can we pay?
You’ll pay after the workshop, we’ll send you an invoice. You can pay via bank transfer.
Who should join from our team?
Best case, the people join who influence product and technical decisions. So, if you’re a team of 3 founders with no employees yet, it might make sense that all of you join.
If you’re a larger company, it usually makes sense that one technical person, one product person and the regulatory person joins.
Ready to get started?
Book an initial 30-minute call with us below to learn more and get started. The first call is free!
Regulatory Strategy Workshop
400€
(+VAT)
Spend two hours with us and get answers to all your EU MDR questions, including classification of your device. Get a plan on how to bring your device to market.
Video call to answer all your questions
MDR classification
Notified body selection
Plan for cost & timeline
Regulatory automation & ChatGPT
Save consultant costs (often 50k€+)
Optimized for startups
Book an initial 30-minute call with us below to learn more and get started. The first call is free!