01
The trace matrix is a second job
Every requirement→spec→test→release link is re-typed into a spreadsheet that's stale before the review even starts.
Engineering & R&D
Design controls that maintain themselves.
Design reviews, test management, risk, traceability, dependencies, releases, and CI/CD — the ISO 13485 §7.3 workload, generated from the engineering work you're already doing.
Built for R&D teams who own design controls and are done maintaining them by hand.
Read-only demo · no signup · sample data only
One platformShared operational data
Role-awareAccess follows responsibility
ConnectedContext follows the record
The problem
Design controls are real engineering work, buried under paperwork.
The §7.3 deliverables are treated as documents to assemble at review time instead of a byproduct of the work itself.
- 02
Risk lives apart from the design
Your ISO 14971 analysis is a document; the design it's meant to govern is somewhere else entirely.
- 03
Nobody can see the real seams
Which R&D sub-team blocks which? The interface contracts and dependencies are tribal knowledge, not a map.
How Azora solves it
Stop maintaining the matrix. Generate it.
Design controls, risk, and releases share one graph — the evidence accumulates as engineers do the work, not at review time.
Design Controls hub
Design reviews, test management, and traceability in one hub — the §7.3 chain built from links you make as normal work.
Risk hub (ISO 14971)
FMEA and risk register wired to the design controls they govern, not stranded in a separate file.
Dependencies & interface contracts
Map the named seams between sub-teams; see what blocks what before it blocks you.
Releases & change control
Compose releases from the work that shipped; signed change control keeps the history straight.
CI/CD & lab
Pipeline status and lab/equipment management alongside the design record.
Genealogy & BOM
Trace a unit to its BOM and its inspection history — engineering and operations share the same graph.
Practitioner perspective
I used to maintain the trace matrix in a spreadsheet — three days a release. Now it's a graph view that builds itself from the link picker. I haven't opened the spreadsheet in two months.
0Manual trace-matrix maintenance
§7.3Design controls generated, not typed
1 graphDesign, risk, tests, releases
Connected by design
Engineering & R&D does not become another silo.
Azora keeps project, quality, operations, people, clinical, and customer context on one operational data layer. Teams can follow the record instead of rebuilding its history in the next tool.
Capture the source
Keep the originating task, study, customer, unit, or people record attached to the work it creates.
Govern the handoff
Route ownership and approvals through role-aware workflows, with controlled history where the record requires it.
Read the same signal
Let downstream teams and leadership work from linked operational data instead of reconciling exports.
See the connected workflow
Let the evidence build itself.
The demo tenant seeds requirements, specs, tests, and releases so you can explore the traceability graph immediately.
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