Opra Start manages the full traceability chain — from user groups and needs through to Intended Use and IFU documents. When anything upstream changes, every downstream document is flagged instantly. No tracking. No guessing. No findings.
The live model shows product operation (capture through notify), the User Need that constrains it, and the IU/IFU that must stay aligned. Edit the need and watch the alert path and downstream docs flag — with reasons on the audit trail. No spreadsheets, no missed updates.
Every feature exists because auditors ask for it. Everything flows from one model: needs → products → documents.
Capture what each user group needs, in what context, with what training level — not as prose in a Word doc.
Demographics, training, environment. This is your IEC 62366-1 Use Specification.
For each group, what they need, in what context. Tag each need's impact on IU, IFU, or both.
Connect needs to products. Opra Start shows coverage gaps — groups without needs are flagged.
Create Intended Use and structured IFU from linked needs. Review and approve with status workflow.
Edit a user need. Every affected IU and IFU is flagged for review, with the reason logged.
Full access to explore Opra Start with your team.
For early-stage teams building their first device.
For growing teams with multiple products in development.
For organizations with compliance-critical requirements.
Start your free 7-day trial. Set up your first product, define user groups and needs, see propagation in action.