Get Free CE-Marking
for Class I Health Apps

Get Free CE-Marking
for Class I Health Apps

Only 5 Spots Available

Only 5 Spots Available

Be 1 of 5 startups to get CE approval – only pay the 1,327 DKK filing fee

We’ll generate your full Technical File and QMS (worth €7,500) for 0 DKK. You only cover the Danish Medicines Agency fee: 1,327 DKK (~€178).

Apply for Program

Apply for Program

Apply for Program

What’s in the Lunchpad Program

Regla Copilot™ (built on Vertex AI/Gemini/O3/ in EU regions) drafts every MDR Annex II section, links evidence, and hands you a submission-ready bundle. We need real-world feedback, so the first 5 teams ride free.

Regla Copilot™ (built on Vertex AI/Gemini/ in EU regions) drafts every MDR Annex II section, links evidence, and hands you a submission-ready bundle. We need real-world feedback, so the first 5 teams ride free.

Apply for Program

Apply for Program

Apply for Program

Who we are

We’re a team of engineers and compliance experts making regulatory approval fast, easy, and accessible for health tech startups.

If you have any questions,

reach out to Emil at +45 71 90 23 82 or [email protected]

We’re a team of engineers and compliance experts making regulatory approval fast, easy, and accessible for health tech startups.

If you have any questions, reach out to

Emil at 71 90 23 82.

Who we are

We’re a team of engineers and compliance experts making regulatory approval fast, easy, and accessible for health tech startups.

If you have any questions, reach out to Emil at 71 90 23 82.

💡 Pay only the 1 327 DKK government fee — our service is 100 % discounted

Let’s talk – book a 15 min call with us 👇

Frequently Asked Questions

What exactly do I get in the Lunchpad Program?
Is it really free? What’s the catch?
Who is eligible?
Do I still need ISO 13485 certification?
Will a notified body accept AI-generated docs?
How does Regla actually work under the hood?
How long does it take?
What data do I have to share?
What happens after the Lunchpad Program?
How do I apply?
What exactly do I get in the Lunchpad Program?
Is it really free? What’s the catch?
Who is eligible?
Do I still need ISO 13485 certification?
Will a notified body accept AI-generated docs?
How does Regla actually work under the hood?
How long does it take?
What data do I have to share?
What happens after the Lunchpad Program?
How do I apply?
What exactly do I get in the Lunchpad Program?
Is it really free? What’s the catch?
Who is eligible?
Do I still need ISO 13485 certification?
Will a notified body accept AI-generated docs?
How does Regla actually work under the hood?
How long does it take?
What data do I have to share?
What happens after the Lunchpad Program?
How do I apply?
What exactly do I get in the Lunchpad Program?
Is it really free? What’s the catch?
Who is eligible?
Do I still need ISO 13485 certification?
Will a notified body accept AI-generated docs?
How does Regla actually work under the hood?
How long does it take?
What data do I have to share?
What happens after the Lunchpad Program?
How do I apply?