Build, Operate & Monitor, ISO 13485 End-to-End
€990/month on the annual plan (€1,190/month month-to-month). For teams > 2 users, funded startups (> €250k raised), or launched devices. Full workspace: eQMS + PLM + Dossier + NPV Financials + PMS.
€1,190/mo month-to-month · save 2 months on the annual plan · unlimited users
The Problem
After ISO 13485 setup you still need to run operations, handle CAPAs, complaints, supplier controls, and post-market surveillance, without losing traceability or audit-readiness.
The Solution
Helix Workspace gives you the full Genesis foundation (ISO 13485 QMS + SOPs + traceability) and adds everything you need to operate and stay compliant: CAPA, complaints, supplier and document control, PMS, PMCF, vigilance, and full QMSR/MDR alignment. Full workspace: eQMS + PLM + Dossier + NPV Financials + PMS. 50% lower cost than legacy eQMS with 3x the capability.
What you get
Everything in Genesis, plus the operational layer to run a compliant company at scale.
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.