Documentation

Set up your workspace, invite your team and create your first project in XyReg.

• Account and workspace setup
• Inviting your team
• Creating your first project

How XyReg generates a complete, audit-ready ISO 13485 quality system in days instead of months.

• What the baseline contains
• A realistic timeline
• Document and record control

Linking user needs to requirements, risk, usability, verification, validation and the design history file.

• The traceability chain
• Live gap detection
• Exporting the trace matrix

How XyReg is validated under AAMI TIR80002-2 and 21 CFR Part 11 — and what revalidation on updates looks like.

• What is included
• Revalidation on updates
• Audit trails and electronic signatures

What Cortex AI drafts, how it is grounded in your data, and the sovereignty boundaries it operates within.

• What Cortex can do
• Human in the loop, always
• Data sovereignty

REST endpoints, authentication, webhooks and the Slack assistant for connecting XyReg to your stack.

• Authentication
• Core endpoints
• Webhooks and events

Roles and permissions, electronic signature controls, ISO 27001 practices and EU data residency.

• Roles and permissions
• Data residency
• Security practices