And exactly how we'd get their regulatory managers to respond
EUDAMED 2026 compliance isn't a future problem. It's happening now. Stressed regulatory teams are hiring, expanding, and looking for solutions. The companies below aren't random. They're showing clear signals that they need what P36 offers.
Each one has a specific trigger. Each one is reachable. Each one needs UDI compliance infrastructure.
Raised €20M Series A in February 2026. MDR Class IIa certified device (myReha platform). Planning DACH expansion + US entry. CEO Moritz Schöllauf has regulatory affairs background.
Scaling across multiple markets means managing UDI data for EUDAMED, FDA GUDID, and potentially Korea's MFDS. Their regulatory team is stretched with growth. P36's multi-market platform solves this.
"Moritz, expanding to the US while managing EUDAMED compliance means your regulatory team is about to hit a wall. We built a UDI platform that handles FDA GUDID and EUDAMED simultaneously. 10 minutes to show you how it works?"
FDA 510(k) clearance achieved. US commercial launch scheduled 2026. Actively hiring Health & Safety Manager and regulatory affairs roles. 25% headcount growth planned globally.
Running dual EU/US operations with Versius robotic system means managing UDI compliance across both regions. Hiring signals they're scaling regulatory infrastructure fast.
"Rob, you're managing EUDAMED for Europe and GUDID for your US launch. Your QARA team is scaling but the compliance surface area is growing faster. We've built the only platform that validates UDI data for both simultaneously. Worth a look?"
Hiring Head of QA/Regulatory Affairs + Quality, Regulatory & Risk Manager right now (both remote, Germany). Building lean, high-performance regulatory team. Software as Medical Device (SaMD) requires strict MDR compliance.
They're scaling their regulatory function. Udo's team will need tooling for EUDAMED UDI management, validation, and submission. P36 makes them immediately productive.
"Udo, your QA and regulatory team is growing. Give them the tools to handle EUDAMED compliance from day one. P36's UDI Platform handles data prep, validation, and submission so they can focus on strategy, not spreadsheets."
£2.2M seed funding raised in 2024 for 3D-printed orthopaedic implants. Early-stage, focused on regulatory readiness, partnerships, and clinical evaluations. Incorporated April 2024.
Early-stage MedTech companies often delay regulatory infrastructure. But EUDAMED compliance isn't optional. They're building toward CE mark and need UDI systems before launch, not after.
"James, you're building regulatory readiness for CE mark. Most startups wait until the last minute to figure out EUDAMED UDI compliance. We help you get it right the first time, no delays, no scrambling."
Raised $150M in November 2025 for Dexter robotic system. Prioritizing US ambulatory surgery center penetration in 2026. Dual EU/US regulatory compliance required.
Swiss engineering, EU presence, US expansion. They need EUDAMED compliance in Europe and FDA GUDID for US ASCs. Managing UDI across both markets manually is a disaster waiting to happen.
"Greg, you're targeting US ASCs while maintaining EU operations. That means dual UDI compliance. P36's platform is built for exactly this: EUDAMED for Europe, GUDID for the US, one system. Let's talk before your regulatory team drowns."
We don't just hand you a list. We find the triggers, write messages that prove you understand their world, and get meetings booked.
We find MedTech companies with real signals. Funding rounds, hiring, FDA clearances, market expansion. Not just databases. Real triggers.
Every message references their specific situation. Their hiring, their timeline, their pain. Not templates. Actual context.
LinkedIn + email sequences. Timing based on trigger events. Follow-ups that reference previous touches. Professional, persistent, never spammy.
Qualified meetings with decision-makers who have budget, timeline, and actual compliance deadlines. Not tire-kickers.