We understand how stressful navigating the certification maze can be, especially when you’re trying to build a great product at the same time. And when the process turns into paperwork instead of progress, it drains the team. That’s why we help Medtech teams prepare the technical file and evidence in a structured way — so you can hand-over for review with confidence, without the scramble.
With more than 20 successful regulatory approvals behind the team, we build certification software from real-world work — not theory or wishful thinking.
For this SPRINGBOARD®, panelists with competencies/experience within these themes, are needed for sparring:
The problem
In med-tech, you can’t sell your product until you prove it is safe and effective. The entire process lacks clarity. When critical paperwork is scattered across tools and documents, you risk failing the final approval. That can cost months and tens of thousands of euros.
The solution
This startup is developing a shared workspace that turns regulatory complexity into guided execution. It brings the roadmap, day-to-day work, and evidence into one place — so progress stays visible, responsibilities stay clear, and nothing critical shows up too late.
The value
This is what changes when the work is connected — not scattered.
• Progress is based on work, not guesswork. A live roadmap shows what’s done, what’s blocked, and what needs attention — early enough to act while changes are still cheap.
• Each person gets exactly the view they need. One shared truth, with views that fit each role from junior to senior — without parallel tools or manual status updates.
• Momentum is kept between handovers. Dependence keeps handovers clean, so R&D, regulatory, and quality stay in step — and progress doesn’t stall.
Price model
Start – EUR 100 monthly. For teams that want a clear plan and daily execution in one place.
• One roadmap board with activities, phases, tracks, dependencies and resource management
• One task management board with tasks you can connect to activities in the roadmap, dependency between tasks, and timeline
Build – EUR 300 monthly. For teams that also want documents with approval and audit trail.
• Everything in Start
• Document management system (DMS) with files, reviews, and approvals
• Quality management system (QMS) with audit trail
Scale – EUR 500 monthly. For teams running one device with multiple workstreams in parallel.
• Everything in Build
• Extra roadmap boards
• Extra task management boards
The Team
A – CEO and founder, with more than a decade in the industry. He has a background as a medical doctor, has built startups before and undertaken positions in global operating companies like Ambu and Novo Nordisk.
B – CTO and founder, with more than a decade’s experience in software development. He holds a PhD in Computer Science, has built startups before and undertaken positions in Google, Microsoft and Audience Project.
