Answers — or a direct line to us.

ISO 13485:2016 (§7.3.3, §7.3.9), IEC 62366-1 (§5.1 Use Specification, §5.2 User Needs), 21 CFR 820.30 Design Controls, EU MDR Annex I, and 21 CFR Part 11 for the audit trail and e-signatures. We map every artifact to its specific clauses.

When you edit a User Need or update a user-group profile, OPRA FLOW flags linked URS entries and cascades downstream to PRS, Intended Use (IU), and IFU documents where applicable. Each flag carries a reason and is logged in the audit trail. You review, approve, and move on — no spreadsheet hunting.

Yes. SaMD teams are our core users. The model — user groups, needs, products, IU, IFU — maps cleanly to software devices, and the quality OS carries the same records through change control, CAPA and training. Coverage analysis is especially useful for identifying clinical workflows where needs are undefined.

Every create, update, delete, approve, and propagation event is recorded with actor, timestamp, and reason. Records are append-only and cannot be edited or deleted. Export to CSV for inspection.

Yes. Each organization has an isolated tenant. Access is scoped at query time; no cross-tenant reads are possible. Enterprise deployments support single-tenant and on-premise options.

Yes. Product traceability exports as .xlsx from the product workspace. The audit trail exports as CSV for inspection and archival.