Pre-revenue founders, ISO 13485-ready in days.
€290/month on the annual plan (€349/month month-to-month). Max 2 core seats. Build your ISO 13485-compliant QMS in days with auto-generated SOPs and full traceability, user needs → risk → usability → V&V. Strictly for pre-revenue, pre-seed/grant-funded teams (< €250k raised).
€349/mo month-to-month · billed annually · 2 core seats
The Problem
Building a medical device without integrated compliance leads to disconnected spreadsheets, broken traceability, and massive regulatory rework before your first audit or trial.
The Solution
Genesis stands up your complete compliance foundation in days. Build with live, automated traceability linking User Needs → ISO 14971 Risk Analysis → IEC 62366 Usability → V&V into an audit-ready Design History File.
What you get
Everything you need to build your ISO 13485 foundation in days.
Add power as you grow
Start lean and unlock more capabilities when you need them.
AI Booster Pack
500 AI credits for document generation and smart advisory.
Blueprint Pro
Full Venture Blueprint: reimbursement, clinical evidence, funding, go-to-market and pitch builder.
Individual Module
Add any module from the catalog a la carte.
Built on European trust
Sovereign European Cloud
Headquartered in Luxembourg and hosted exclusively on EU-owned OVHcloud infrastructure. Your data stays under EU jurisdiction, outside the reach of the US CLOUD Act and aligned with Schrems II requirements.
ISO 27001 Infrastructure
Running on hosting infrastructure certified to ISO/IEC 27001, ISO 27017 and ISO 27018. GDPR compliant, with safeguards designed for health data.
Validation in Minutes (ISO 80002-2)
Skip weeks of manual computer software validation. XyReg delivers pre-packaged, risk-based validation evidence following AAMI TIR80002-2 and ISO 13485 section 4.1.6 in minutes, not days.