Opra Start manages the full traceability chain from user groups and needs through to Intended Use and IFU documents. When anything upstream changes, downstream documents are flagged instantly.
Free for 7 days · No credit card required
Built for regulatory compliance
Not a document repository. Not a spreadsheet. A purpose-built tool that understands regulatory traceability.
Capture what each user group needs, in what context, with what training level. Attach to products with impact types (IU, IFU, or both).
ISO 13485 7.3.3Edit a user need or update a user group profile — Opra Start instantly flags every affected IU and IFU document. No manual tracking.
ISO 13485 7.3.9See at a glance which intended user groups have needs defined and which don't. Auditors look for this — Opra Start surfaces gaps before they do.
IEC 62366-1 5.1Draft your IU statement from linked user needs. Review and approve with a status workflow. Outdated flags ensure it always reflects reality.
21 CFR 820.30(c)Structured IFU sections: indications, contraindications, warnings, target users, step-by-step instructions. All traced back to user needs.
EU MDR Annex I 23.4Every create, update, delete, approval, and change propagation event is logged with who, what, when, and why. Tamper-proof by design.
21 CFR Part 11Describe who uses your device — demographics, training, environment, frequency. This is your IEC 62366-1 Use Specification foundation.
For each group, define what they need to do, in what context, and why it matters. Tag each need with its impact on IU, IFU, or both.
Connect needs to products and assign intended user groups. Opra Start shows coverage gaps — groups without needs are flagged instantly.
Create your Intended Use statement and Instructions for Use from linked needs. Review and approve with a built-in status workflow.
Edit a user need or update a group profile. Every affected IU and IFU is automatically flagged for review, with the reason logged in the audit trail.
We spent weeks tracking user needs in spreadsheets. Opra Start replaced that with a system that actually flags when our IU is out of date.
The coverage analysis caught a gap we'd missed — an entire user group with no needs defined. That would have been a finding in our audit.
Change propagation is the killer feature. We changed one user need and instantly saw which IFU sections needed updating. No more guessing.
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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, and see change propagation in action.