End-to-end traceability
Traceability is where most audits are won or lost. In XyReg the chain is a live data model, not a spreadsheet you rebuild before every audit.
The traceability chain
- User needs — captured from clinical input, market requirements and intended use.
- Design inputs — testable requirements derived from those needs.
- Risk controls — hazards, harms and mitigations per ISO 14971, linked to the requirements that implement them.
- Usability — use-related risks and tasks per IEC 62366-1, linked into the same risk file.
- Design outputs — specifications, drawings and software items.
- Verification and validation — protocols and results linked back to every input.
- Design history file — assembled automatically from the links above.
Live gap detection
XyReg continuously flags orphans: a requirement with no verification, a hazard with no control, a control with no evidence of effectiveness. You see the gaps while you are developing, not the week before a notified body visit.
Exporting the trace matrix
Generate a trace matrix in one click as PDF or spreadsheet, snapshotted to a specific date and revision so it matches exactly what an auditor is reviewing.