For medical device innovators
Opra Start gives you the structure to move fast — capturing your users, their needs, and your product vision so you can iterate, pivot, and build without ever losing your foundation.
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.
Start with who you're building for and why they need it. Every decision after that — product definition, risk, planning, build — traces back to that foundation automatically.
Who are you building for? What do they actually need? Opra Start guides you through the questions that matter — in plain language, not technical frameworks — and builds your product definition from those answers.
User needs → intended useModel, iterate, refine. Your product requirements trace automatically to the user needs behind them. Pivot freely — the connection is maintained. Every version of your thinking is captured, structured, and connected.
Intended use → requirementsWhat you build in Opra Start is the foundation for everything that follows — risk, planning, build, assets, all the way to OPRA FLOW. Add each product when your work demands it. Never pay for infrastructure you haven't grown into yet.
Requirements → everythingFull 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.
Not every company starts at stage one. The constellation meets you where you are — and each product activates only when your work genuinely needs it.
Contact us for timelines and interest in the entire collection.
Product definition
Guide a team from ideation to a fully traceable product definition. User groups, needs, URS, Intended Use, PRS — all linked, all audit-ready.
Risk management
Extends OPRA START into ISO 14971 risk management. Every risk control in your PRS links back to a hazard. Benefit-risk analysis built in.
Design controls
Project management built for medtech. Understands design-control phases and generates ISO 13485-compliant project plans with the correct document gates.
Parts & BOM
A structured parts library and BOM builder. Every part carries its regulatory attributes. Component changes propagate to affected documents and risk files.
Asset management
Full lifecycle for lab equipment, test instruments, and manufacturing assets. Calibration, maintenance, qualification — maintained automatically, linked to V&V.
Audit automation
Continuously monitors your quality system against ISO 13485, EU MDR, and FDA. Identifies gaps, recommends CAPAs, produces evidence packages on demand.
Supplier management
Supplier qualification and ongoing control. Approval workflows, technical questionnaires, audit scheduling, AVLs — connected. Supplier changes trigger impact assessments.
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. We map every artifact to its specific clauses.
When you edit a User Need or update a user-group profile, Opra Start 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. 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 tier supports single-tenant deployment and on-premise.
Yes. Product traceability exports as .xlsx from the product workspace. The audit trail exports as CSV for inspection and archival.
Start your free 7-day trial. Set up your first product, define user groups and needs, see propagation in action.