One platform for requirements, architecture, tests, risk and SBOM
TraceUnified unifies the entire development and verification lifecycle — requirements, architecture, tests, risk, and connected SBOM — in a single traceability graph. Change one artifact and every linked item flags for re-verification, automatically. License all five modules, or just the one you need today.
Click Analyze on a requirement and AI checks it — gaps, conflicts, weak verifiability — and proposes a rewrite, on a model you bring. It proposes; you decide. It never touches your traceability.
Start free in a populated, industry-specific workspace — not an empty shell. yourteam.traceunified.com
| Source | TC-220 | TC-221 | TC-222 | TC-223 | TC-224 |
|---|---|---|---|---|---|
| 🔒 REQ-014 Bolus dose accuracy | ✓ | ✓ | ! | ||
| REQ-015 Occlusion alarm latency | ✓ | ✓ | |||
| REQ-016 Battery low warning | ✓ | ✓ | |||
| ⚠ REQ-017 Reservoir volume display | |||||
| 🔒 REQ-018 Basal rate scheduling | ✓ | ✓ | ✓ |
The problem
Requirements in one system, architecture in another, tests in a third, risk and SBOM somewhere else. The trace between them is a spreadsheet someone rebuilds by hand before every audit — and every boundary between two tools is a seam where the thread quietly breaks. The broken link is exactly what an auditor finds.
Each tool owns one link in the chain. None of them owns the whole thread.
How it works
Requirements, architecture, tests, risk and SBOM are linked records on one model. Review, approval, versioning, training, audit, reporting, import and release work the same on every module — and a governed AI assistant reads across the whole connected model: it proposes, you decide, on a model you bring, and never edits the record.
The platform
Each pillar is a real, deep capability — not a thin module. What no point tool can offer is the connection between them: it's the same data, so the thread is intrinsic.
Author, version, and baseline requirements as governed items. Relationship rules define what may link to what, so the trace model is enforced — not left to convention. Optional AI flags ambiguous or untestable language as you write.
Activity diagrams, allocation and satisfy/verify matrices, and model validation — with elements trace-linked to requirements and tests in one database. No ReqIF round-trip, no drifting copies.
Build test plans, execute runs with pass / fail / blocked steps, track milestones, and log defects from failed results — each linked back to the requirement it verifies.
Score risks, link mitigations to requirements and tests, and surface residual risk. When a mitigation changes upstream, the linked risk flags for review.
Import CycloneDX and SPDX bills of materials, reconcile components by package URL, and track vulnerabilities against the components your product actually ships.
Scope & licensing
TraceUnified is licensed per module. If requirements are all you need, license Requirements — nothing else appears, and nothing else is billed. Add tests, risk, architecture, or SBOM when the work asks for them. Two engineers or two hundred; the platform doesn't care how big the project is.
Included with any license, however few modules you take:
Taking several? Core (Requirements + Tests), Professional (+ Risk) and Enterprise (+ Architecture) bundle them at a lower rate than buying each alone. See how licensing works →
Signatures, approvals and controlled states are configuration. Electronic signature is a checkbox on a workflow, and it ships off — turn it on for the workflows that need it, and only those.
Same data, same graph, same tool. The team shipping a consumer app runs the left column and never sees a signature dialog. The team filing a 510(k) turns the right column on — and because the history was there all along, the evidence is already written.
See it in action
Start free in a populated, industry-specific workspace — the whole thread, already linked. Not an empty shell.
Governed AI
TraceUnified's AI is a governed advisory layer. The agents analyze and propose — they never write to your records. A human applies every change through the signed, audited workflow. AI is additive, never authoritative — the thread stays deterministic, every link still explicit and human-made.
OpenAI · Azure OpenAI · Anthropic · your own endpoint
See how the governance works →The derivation engine
Point the engine at a set of requirements and it proposes the downstream work products they imply. Every item cites a real source; you accept what's right. The record only ever changes by human action.
Connected SBOM
The FDA now requires a machine-readable SBOM in premarket submissions for connected devices — and can refuse one that's missing it. But a component list in a separate tool answers nothing when a CVE drops. In TraceUnified every component is a first-class item on the same trace graph as your requirements, risks, and tests — so a vulnerability flags exactly which hazards it threatens and which tests cover it.
1 upstream · 2 downstream · CVE flagged → 1 risk now suspect, re-verification required
Compliance spine
The controls a regulated submission depends on are part of the data model, not a plug-in — so turning them on is configuration, not a migration. Projects that don't answer to a standard leave them off and lose nothing. Projects that do switch them on and find the evidence already written.
Available on every project · enforced only where you enable it
One spine, configured to the standard you answer to:
Industries
One traceability model. Tune it to the standard you answer to — or to no standard at all. We lead where we're sharpest, medical device, because that's the hardest version of the problem; teams with nothing to certify run the same platform with the compliance controls left off.
The sharpest fit — design history, V&V traceability, risk, and e-signatures in one record. Demo content ready today.
Objectives traced from requirements through verification.
Functional-safety work products linked across the lifecycle.
Safety functions traced to tests and evidence.
One model from spec to verification.
Software, hardware, internal tools. The same traceability and the same modules — with the signatures and approvals switched off.
See it for yourself
Start a free trial and land in your own isolated workspace with a populated, industry-specific project — the whole thread, already linked. Judge it on the work.
yourteam.traceunified.com