Getting started with XyReg
Everything you need to go from an empty workspace to a working, audit-ready environment. Most teams complete this in a single afternoon.
Account and workspace setup
Start your 7-day trial and XyReg provisions a dedicated workspace hosted in the EU. During setup you choose your organisation name, your device class and the regulatory routes you intend to pursue (EU MDR, FDA, or both).
These answers shape the baseline: the SOP set, the risk templates and the dossier structure XyReg generates for you.
Inviting your team
Invite colleagues by email from Settings → Team. Every user gets a named account with a personal audit trail — shared logins are never permitted in a regulated system.
- Genesis includes 2 named users; add-on modules are €50/month each.
- Helix Workspace includes your full team plus all packs.
- Roles: Admin, Quality, Engineering, Read-only, External auditor.
Creating your first project
A project in XyReg holds one device or device family. It carries the design history file, the risk file, the usability file and the linked financial model, so nothing lives in a separate spreadsheet.
Import what you already have — existing SOPs, risk tables and requirement lists can be uploaded as documents or CSV, and XyReg maps them onto the standard structure.