The Startup Challenge
Building a medical device company is hard. The regulatory maze makes it even harder.
Regulatory Complexity
Navigating MDR, QMSR, FDA 510(k), and international requirements without dedicated regulatory expertise is overwhelming and expensive.
QMS from Scratch
Building a Quality Management System that satisfies auditors while remaining practical for a small team seems impossible.
Investor Readiness
VCs want to see regulatory progress, but most startups can't demonstrate it clearly, leading to undervaluation or missed funding.
Xyreg: Your Regulatory Co-Pilot
We've built the operating system that MedTech startups need, combining project management, quality management, and financial tracking in one integrated workspace.
Why Startups Choose Xyreg
Pre-built templates for ISO 13485, MDR, and QMSR compliance, no regulatory consultant needed to start
Guided workflows that walk you through Design Controls, Risk Management, and Clinical Evaluation step-by-step
Real-time rNPV tracking that shows investors your true risk-adjusted value as you hit milestones
Plan-based pricing tied to your stage, not a per-seat licence for every teammate
Xyreg Cortex AI that helps draft documentation, identify gaps, and accelerate submissions
The Triple Helix Advantage
Most startups fail because Engineering, Regulatory, and Business teams work in silos. Xyreg's Triple Helix synchronizes all three tracks in real-time.
Your Journey with Xyreg
From ideation to post-market, we guide you through every phase
Ideation & Feasibility
Define your device concept with built-in risk assessment frameworks and market opportunity analysis.
Design & Development
Execute Design Controls with guided workflows, automatic DHF generation, and real-time traceability.
Verification & Validation
Plan and execute V&V activities with protocol templates, test tracking, and deviation management.
Regulatory Submission
Generate submission-ready dossiers for FDA, MDR, or other markets with automated document compilation.
Post-Market Surveillance
Monitor your device in the market with CAPA management, complaint handling, and vigilance reporting.
The Genesis Program
Built for pre-revenue MedTech teams: €290/month on the annual plan, starting with a 7-day free trial
7-Day Free Trial
Start free for 7 days, cancel any time at no cost. After that Genesis is €290/month on the annual plan (€349 month-to-month).
Pre-Built Templates
Start with industry-standard templates for Design History Files, Risk Management, and Quality procedures.
2 Core Seats
Genesis is sized for founding teams: two core seats, pre-revenue, under €250k raised. Upgrade to Helix Workspace as you grow.
Shape the Product
As a Genesis member, you get direct access to our product team to influence the roadmap.